Process Development Resume Samples

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O Beahan

Ocie

Beahan

830 Carlo Parks

New York

+1 (555) 117 7379

830 Carlo Parks

New York

Phone

p +1 (555) 117 7379

Experience Experience

Philadelphia, PA

Process Development Technician

Philadelphia, PA

Schoen-Hermiston

Philadelphia, PA

Process Development Technician

Bring engineering expertise to new product development and applies best practice in scale-up and process development to ensure quality and capacity targets
Perform validation and prototype work to implement and verify designs during the process development phase
Develop management of change requests, operating procedures logs, etc. and provide training related to technology transfer functions
Support of the development of manufacturing technology and capabilities for new/improved products and processes
Candidate shall be a highly motivated self-starter with a positive attitude, excellent work ethic, sound focus on safety and strong initiative
Startup and operation of 3-D metal printer for high-performance refractory alloy components
Assisting with the build, wiring, piping, testing and implementation of bespoke assembly equipment

San Francisco, CA

Process Development Associate

San Francisco, CA

Rolfson Inc

San Francisco, CA

Process Development Associate

Performs experiments following Process Development protocols
Reviews and updates process development related protocols and SOPs
Mathematical modeling, experimental design and data analysis supporting biologic process development
Assists with the scale-up & technical transfer of cell culture and purification processes to GMP Manufacturing
Prepare written and oral reports for presentation to the development group and senior staff
Analysis of data by statistical or DoE software, and graphical procedures in order to provide accurate, concise and pertinent summaries and data reports
Creates and submits simple standard operating procedure (SOP) changes

present

Chicago, IL

Process Development Manager

Chicago, IL

Champlin, Feil and Smitham

present

Chicago, IL

Process Development Manager

present

Lead, manage and develop the Process Development team in Monthey
Assure that critical success factors for Process Development are captured in KPI's. Use these to drive and continuously improve the performance of the group
Maintain project management software/database that provides live status to corporate partners
Drive the pro-active uncovering and development of new “out-of-the box” process ideas to grow the business leveraging on consumer insights, market trends, industry practices and innovative technology
Manage and develop the Safety Lab Unit to comply with the highest Process Safety standards
Work cross-functionally with Product Development, Quality & Food Safety, Analytical, and Material Science teams in the manufacture, development, and use of cocoa extract
Develop and implement new processes from initial concept through implementation. Independently manage assigned projects coordinating closely with international business partners, Marketing, Sales, Supply Chain, Finance, Legal and the cross functional R&D team

Education Education

Bachelor’s Degree in Food Science

Bowling Green State University

Bachelor’s Degree in Food Science

Skills Skills

Ability to persuade, influence and collaborate with others to achieve common organizational goals. Capable of comfortably interacting with senior leaders
Highly adaptable to change
Thorough knowledge of pharmaceutical manufacturing processes, equipment and testing procedures
Ability to chart the future in an ambiguous environment
Excellent communication skills
Working knowledge of pharmaceutical ingredients including the understanding of chemical and physical properties of active ingredients and excipients
Working knowledge of Design For Six Sigma Principles
Ability to complete projects independently with little supervision
Ability to coordinate multiple projects and perform multiple tasks at the same time
Ability to identify risks and benefits, and make appropriate business recommendations

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Process Development / Improvement Management Resume Examples & Samples

Build and manage project plans for field/client impacting initiatives
Work effectively with other business units to execute projects, to end of life, including roll out of new/modified products, new processes or procedures, re-skilling, etc
Lead cross functional projects that develop tools and resources to enable fields’ optimal productivity and performance
Align with partners to confirm business priorities and de-conflict competing initiatives
Support innovative tool development and tracking mechanisms
Focus on continuous improvement
Proven interpersonal, oral and written communication skills to enable success of team while adding value as individual
Relevant project management, planning and/or consulting experience
Champion of Change- track record of assessing big picture, creating plan of action, gaining alignment, driving change through others
Innovative problem solver plus comfort making/driving decisions
Client focused orientation: excellent client management/relationship management skills
Strong attention to detail, balanced by ability to see how initiatives complement overarching strategies
Resilience in a constantly changing environment, flexible & adaptable
Excellent partnering skills yet can work independently
3+ years relevant industry experience
4+ years process/product development experience driving concepts through implementation and adoption
Bachelor's Degree required or equivalent work experience
Proficient in PowerPoint, Excel Word, SharePoint; strong computer skills a must

Director Process Development & Analytics Resume Examples & Samples

Root cause analysis
Predictive analytics
Policy creation
Create and drive vision to improve member experience through analytics and process creation
Demonstrate a comprehensive understanding of the relationship between business needs and analytics/technological solutions
Influence others to gain support for initiatives or changes that will improve business member experiences and reduce complaints; facilitate productive relationships with other analytics centers, technology and operations departments
Focus on continuous improvement opportunities within the Resolution team or other areas of the organization to reduce complaints
Establish solid relationships with all business groups in order to understand on-going business needs. Identify potential improvements in processes and then develop and implement new procedures needed to support changes, efficiencies and expense reduction in the business
Partners with senior management to make far reaching and broad decisions
Master’s degree of Engineering, Informatics, Public Health, Business Administration, Econometrics, Information Technology, Mathematics, Statistics or a related field or equivalent experience
Experience leading teams engaged in analytics and the development of actionable business insights and/or business solutions; has led others in Analytic or technical roles
Passion for solving problems; proven ability to draw analytics insights and communicate outcomes effectively to all levels of project and program stakeholders
Minimum of 3-5 years planning, managing and delivering complex, large scale, cross-functional projects or programs
Experience using one or more cutting edge technologies and applications in analyzing large, dynamic data sets – examples include, SAS, SQL, Qlikview, Tableau, etc
Experience creating analytics processes and driving transformational change that improves the consumer experience
Ability to successfully bridge the gap between various analytical, operational and technical functions; can communicate appropriately with all areas of the enterprise
Experience with developing strategic analytics programs
Problem solving utilizing innovative or creative approaches
Experience leading teams engaged in cutting edge analytics of Big Data
5+ years’ experience in Data Science, statistics, predictive modeling, text mining, machine learning or similar advanced analytics capabilities
Application of data-based problem solving methodologies, such as Six Sigma in order to complete complex root cause analysis

Business Systems Process Development Manager Resume Examples & Samples

Migrate demand management, planning, and purchasing activities to Oracle-based processes
Properly integrate appropriate bolt-on modules such as Demantra and Agile to increase capabilities and efficiency
Implement processes to support the following activities: Product forecasting, Purchase order placement, Asset tracking, Engineering change control, Spare inventory management
Implement a product cost analysis tool that allows cost changes to be easily tracked and reported (Q/Q trends, automatic quote uploads, possible on-line commodities RFP/RFQ)
Contribute to scalable BOM structure design in order to better manage manufacturing and service needs
Be the supply chain representative for IT system tool selection
Develop process system specifications to clearly document the requirements to IT
Facilitate CRP activities to validate system/process capability prior to go live
Prepare written process documentation
Conduct user training

Technician, Process Development Resume Examples & Samples

Reviews formulations and manufacturing procedures with Supervisor, or Process Development Technicians, and TSO Process Engineers, gathers and accurately weighs raw materials to be utilized in preparing pilot batches
Transfers phase ingredients to kettles, blenders or various types of equipment necessary in the preparation of pilot batches
Performs general laboratory functions, such as: viscosity and ph measurements, various process control testing and studies under close supervisory direction and recording of pertinent data
Maintains Pilot Lab equipment when necessary and practices good laboratory techniques and procedures
Must have a high school diploma or related training in Chemical processing
6 months previous work experience or related training in process development
Machines/Instruments Used: Personal Computer, Media Mill, High Pressure Homogenizer, Colloid Mill, Micro-Pulverizer, Speed Controllers, Pumps, 3-roll Mill, Homogenizers, Blenders and various laboratory equipment, kettle systems, heating/cooling-utilities etc
Ability to distinguish colors for shade adjustments preferred
Mechanical aptitude preferred
Six month on-the-job training to become familiar with procedures
Good attendance/lateness record
We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply

Pmti Process Development & Deployment Analyst Resume Examples & Samples

Bachelors of Computer Applications
Understanding of Ford engineering timing, design and information management systems and tools (GPDS, FSMS, e2KS, PeBod, eDVPR, eDeviation, WERS, 6-Sigma)
Experience in manufacturing and assembly environment
Knowledge of systems engineering concepts and implementation
Knowledge of Ford Automotive Procedures for PD (ie, DV & PV, ES, CTQ, Non-Compliances, Design Rules, Engineering Sign-off)

Craftsperson Process Development & Technology Resume Examples & Samples

Vast knowledge of all jewelry manufacturing skills
Able to train others in HD techniques and quality levels, including techniques
Ability to communicate with all levels on a daily basis is necessary
Demonstrations on HD jewelry manufacturing
Wide knowledge of all diamonds, metals and surfaces used in the jewelry manufacturing process is vital
Able to work in a production environment
5-10 years of jewelry manufacturing experience
Degree in Design/Technical school preferred
Some experience preferred in design layout utilizing system programs (CAD/CAM)
Ability to work non-standard hours during peak business periods

Technology Director Cybersecurity Process Development Resume Examples & Samples

Work with cybersecurity service managers to mature processes
Develop strong relationships to facilitate current state analysis and target state recommendations
Develop performance metrics and monitor impact of improvements
Develop consistency and drive quality in process and procedural documentation
Contribute to the establishment of continuous improvement discipline across the core services
Minimum of 10+ years of experience working in technology and/or process improvement initiatives using systems thinking
Highly-motivated leader able to handle a high level of complexity and dynamic priorities
Excellent interpersonal and communication skills – ability to facilitate, negotiate, and influence technical discussions
Knowledge of cybersecurity is not a requirement, but preferred
Excellent presentation and documentation skills – expert in PowerPoint, with experience in management reporting and graphic design of systems and workflows

Process Development Manager Resume Examples & Samples

10 years of experience in a Financial Services organization
6 years of process improvement and project management
Six Sigma or similar certification

Global Process Development & Engineering Leader M Resume Examples & Samples

20% Develop and Gather detailed knowledge pertaining to an area of expertise
20% Provide technical/project management support for strategic business unit development and growth activities
20% Partner with Technology team to scale-up new products and processes into existing plants, new plants and 3rd party partners
10% Provide technical support as manufacturing lead for discovery, qualification and ongoing support of 3rd party partners
10% Identify, share and institutionalize best practices and process design by understanding, documenting and deploying them globally and across the enterprise
10% Develop standard for employee training and development relating to the center of expertise
10% Perform miscellaneous job-related duties as assigned
8 years of operations management, process development, engineering and/or R&D experience
3 years of project management experience
Proven experience executing capital projects
Experience with capital projects over $2,000,000
Experience with Process Safety Management (PSM)
Understanding of chemical conversion processes, for example hydrogenation, esterification
Demonstrated experience with “pilot to commercial” scale-up processes
Demonstrated ability to develop in-depth technical understanding of complex operational and business activities and implement those concepts across broad geographies
Demonstrated ability to direct and lead people, with diverse backgrounds, to accomplish business objectives
Demonstrated entrepreneurial skills in the areas of customer focus, innovation, and achieving business results
Demonstrated knowledge of process development, new product implementation
10+ years of operations management, process development, engineering and/or R&D experience
Oleochemical and/or specialty chemical operations management or engineering experience
Proven experience executing capital projects with budgets >$10MM
Experience leading Project Delivery Process teams
Previous experience with batch process operation
Experience with identifying toll producers and developing production contracts
Prior experience with continuous improvement activities and methodologies (i.e. Six Sigma, Root Cause Analysis, etc…)

Process Development Manager Resume Examples & Samples

Team spirit
Chimical engineering degree, extraction, distillation, all evaporation technics, filtration etc
Safety , Hygiene, environment and reglementary oriented
Autonomous, trouble shouting oriented, versatility, , polyvalence oriented
Master degree in chemical ingeneering or equivalent
Experience of 2-5 years in same domain/area appreciated

Advanced Process Development Lead Resume Examples & Samples

Communications - Acts as initial and primary interface between the Advanced Engineering teams and Advanced Manufacturing
Established and maintains clear communication links with the Advanced Engineering Teams
Knowledgeable of the 5 yrs product plan, 5+ Asset life plan and Factory master plans for the category
Communicate and understand Process technology Roadmaps, Process Technology development charts and Process technology opportunity sheets
Develop communication plans and recommendations for process technologies leveraging Agile Mfg concepts based on established priority
Process technology development - Based upon established Platform and Plant needs, work with internal and external process partners resolving knowledge gaps
Develops Process technology development project plan to resolve assigned process knowledge gaps, leveraging AM PTO process, resolving manufacturability issues
Knowledgeable of alternative process approaches
Align deliverables and output of Advanced Manufacturing with process partners, Platform and Manufacturing Leads
Support product leadership goals by driving the use of Agile processing into the platforms, regions and plants
Knowledge transfer and Common Manufacturing Processes -
Acts as the overall AM Subject Matter Expert for category
Global understanding of category specific plants with deep understanding of existing processes
Provide and document manufacturing best practices and provide knowledge transfer resulting in consistency of processes leveraging the AM BoP process
Deep understanding of processes with the category via Process technology scanning and able to strategically visualize benefits in support of DPL
Drives global consistency of processes within the category (BoP compliance)
Early and new project development
Support feasibility assessments for various manufacturing scenarios that spread across multiple regions and plants with multiple platform
Assist in driving capital efficiency
Coordinates category specific Agile Technical Focus Team (TFT) activity
Component level design support for new to the world products

Process Development Engineering Technician Resume Examples & Samples

Under the limited direction of a Process Development Engineer, support the development of new manufacturing processes
Create methods to evaluate product performance relative to engineering specifications
Execute product testing utilizing mechanical test equipment in a laboratory setting
Create and update documentation such as Technical Notes, Drawings and Operator Instructions
Develop equipment and processes in support of new or updated manufacturing needs
Evaluate and suggest alternative/improved methods for manufacturing processes
Complete equipment installation documents(specifications, drawings, maintenance procedures and qualification protocols & reports)
Develop and execute studies supporting the development of new process specifications (Utilize DOE and basic statistical analysis tools; Interpret results of testing)
Support the training of product builders when new processes are implemented in the production environment
Assume responsibility for sub-projects in support of the overall project
Record and document all projects, tasks and results per lab notebook/Spencer SOP’s as well as QSR/ISO procedures

Process Development Associate Downstream Resume Examples & Samples

Conducts experiments in Process Development laboratory following protocols and accurately documents procedures and results in lab notebooks. Drafts experimental protocols and executes experiments under supervision
Performs data analysis, and prepares results summaries and reports
Authors and/or reviews GMP batch records and SOPs, as required
May author and/or review GMP-related documents such as material specifications, deviation reports, as required
Responsible for maintaining laboratory, including supplies inventory, glass wash and waste disposal under EH&S guidelines
Responsible for routine maintenance of laboratory equipment
May cross train and/or focus in various tasks including upstream and downstream GMP manufacturing. Remains current in GMP training and maintains GMP environment when working in manufacturing suites
Completes analytical testing as needed to support manufacturing activities
Assists in training GMP personnel in the implementation of new production and manufacturing procedures. May train new personnel in Process Development

Associate Director, Process Development Resume Examples & Samples

Collaborate within cross-functional teams, specifically with Chemical and Analytical Development to define and execute development strategies that enable successful launch of Alkermes products
Implement scale-up strategies for drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization
Apply reaction engineering and process modeling in development activities. Identify and deploy new technologies as needed
Design crystallization processes that deliver solids of desired attributes
Author & review CMC sections of regulatory filing documents
Mentor fellow engineers
MS in Chemical Engineering with 15+ years of experience
PhD in Chemical Engineering with 10+ years of experience
Proven ability to apply scientific principles to design, execute and interpret experiments
Experience in drug substance crystallization
PAT experience & chemometrics (e.g. ReactIR, Raman, FBRM)
Experience in working with DEA controlled substances

Senior Assistant, Process Development Resume Examples & Samples

Assists in the development of scalable processes with improved product yield and reduced costs for manufacturing systems
Reviews and modifies process development related protocols and SOPs
Acquires knowledge and skills to perform a range of downstream processes, including column chromatography and various forms of filtration
Troubleshoots purification processes that are semi-complex under supervision
Assists in the research and implementation of new methods and technologies to enhance operations
Responsible for routine maintenance of R&D equipment
Maintains cGMP environment when working in manufacturing suites and remains current in GMP training
May train new personnel in process development procedures
Drafts experimental design, tech transfer reports, and development reports

Director, Biologics Process Development Resume Examples & Samples

Managing internal laboratories and external contract manufacturing organizations during all upstream mammalian cell culture and downstream process development ranging from vial thaw, inoculum, media development, media optimization, bioreactor operations and all downstream processing operations for drug substance manufacturing
Providing scientific, technical and engineering expertise, including designing, optimization, scaling and characterization, for all mammalian cell culture process development and downstream processing operations for the generation of recombinant protein therapeutic products with a focus on enzymes used for enzyme replacement therapies
Undertaking studies to characterize the protein manufacturing process to determine critical process parameters and material attributes and their relationship to product quality attributes and process performance
Overseeing and managing process characterization and process validation studies, as well as technology transfers
Leading upstream and downstream process related technical troubleshooting including deviation handling and investigations
Staying current with new technologies and process innovations for biologics development and manufacturing
Understanding Intellectual Property (IP) landscape for recombinant protein therapeutic products
Contributing to CMC regulatory submissions
Establishing effective working relationships with Science department
Strong Scientific and Engineering expertise leading upstream and downstreamprocess development for the generation of therapeutic enzymes
Experience managing relationships with external contract manufacturers and managing technology transfer processes
Experience setting up in-house process development laboratories
Solid Knowledge of current Good Manufacturing Practices (GMPs)
Knowledge and expertise in process modeling, Quality by Design (QbD), Design of Experiments (DOE), Risk Assessments and FMEA
Strong people’s management and mentoring ability
Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others
Ability to produce highest quality and timely work product/ documents with limited direction
A superior work ethic and a strong personal desire for success
Can serve as an example to all employees by demonstrating and modeling behaviors essential to success at all levels
Must be passionate about Amicus and rare/orphan drugs
Advanced skills in Excel and PowerPoint

Undergrad Co-op Process Development Resume Examples & Samples

Work on specialized statics software such as MiniTab
Be enrolled in school under the Coop program
Problem Solving requiring the application of scientific process
Basic Technical report writing
Basic Technical presentation
Analytical Problem Solving
Ability to work with data analysis
Ability to work under pressure and independently with minimal supervision with periodic review if results

Head of Laboratory Formulation & Process Development Late Stage Resume Examples & Samples

As Head of Laboratory you take responsibility for securing effective and efficient development of biopharmaceuticals by driving decisions with national and international partners, as well as with regulatory agencies
You manage a complex, highly scientific and matrix oriented organization effectively
Evaluation and implementation of new technologies to ensure a continuous state of the art pharmaceutical

Director of Downstream Process Development Resume Examples & Samples

Provide all aspects of protein purification development support (see below) to ensure success of matrixed project teams
Partner with matrix Development, Clinical Manufacturing and Manufacturing Sciences organizations to ensure seamless transition and transfer of processes. Coordinate experiments with matrix teams to ensure rapid achievement of objectives and overall process transfer goals
Implementation of novel purification approaches as necessary to enhance BMS’ competitive advantage
Direct continuous process improvements for the group and matrix organizations
Manage budget and equipment acquisition and potential expansion
Provide performance feedback, coaching, career development and mentoring to each team member to ensure their success and fulfilment
Design and set the agenda for a high performing purification development team
Develop and guide the technical agenda for multiple protein therapeutics platform purification
PhD in Chemical/Biochemical Engineering, Biotechnology, Protein Chemistry or Biochemistry
Minimum of 12 years of experience in Process Development/Purification Process Development
Track record of successful implementations of a robust purification process from development to a commercial setting
Track record of demonstrable management skills of multiple projects and technical teams
Experience with all aspects purification development unit operations, including Protein A, Ion Exchange, and Hydrophobic Interaction with different modalities
Experience with scale up and scale down models for multiple therapeutic proteins
Experience with manufacturing organizations and commercial manufacturing organizations
Demonstrated experience in technical transfer of commercial processes
Understanding of established and current trends of ICH and regulatory agencies
Working knowledge of analytical sciences
Working knowledge of upstream and primary recovery
Working experience of Design of Experiments
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Senior Director, Process Development Resume Examples & Samples

Provides strategic leadership, technical expertise, and specialized knowledge in process development for aseptic manufacturing of sterile drug products and drug/device combination products
Provides necessary planning, organization, prioritization and coordination of the process development activities to meet timelines and Corporate goals
Provides strategic leadership for process scale-up, equipment design requirements, and process improvements and coordinates closely with manufacturing and equipment engineering
Applies scientifically-driven thinking to the development of scientifically sound, well understood, and robust manufacturing processes
Coordinates with other internal departments to develop processes and review/approve qualification/validation of manufacturing processes
Leads development of processes and procedures in support of new product development and production of nonclinical and clinical drug supplies
Leads manufacturing process transfer, qualification and validation to commercial production and provides ongoing support as needed to ensure a smooth transition and ongoing manufacturing excellence
Directs, prepares and delivers technical reports, documents, batch records, SOPs, and development reports, etc. for regulatory submissions
Serves as SME for areas of responsibility during regulatory inspections
Keeps up to date with regulatory requirements including those of the FDA and various international regulatory governmental bodies
Degree in chemical engineering, chemistry or other scientific discipline (graduate degree is preferred)
10 years or more in the pharmaceutical industry with a minimum of 8 years in process development and scale-up
Experience in aseptic manufacturing of sterile drug products is required
Experience manufacturing drug/device combination products is a plus
Experience with manufacturing of proteins and peptide is preferred
Hands-on experience with process development and manufacturing
Experience with managing internal and external vendors and service providers
Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to production of pharmaceutical products
Outstanding problem solving abilities
Ability to recognize the potential of new technologies to meet analytical testing requirements
Detail-oriented, with good organizational and project management skills. Ability to effectively prioritize and deliver on tight timelines
Good oral and written communications skills; proficient with MS Word, PowerPoint, Excel

Associate Director Biologics Process Development Resume Examples & Samples

Manage and support development, scale-up, production and tech transfer of processes within or between CMO's
Design and manage cell line development, cell bank creation and safety and stability testing
Debottleneck and rationalize processes to optimize processes consistency, yield, and robustness
Generate, treat and analyze experimental data to support process observations/hypotheses
Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO
Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND, BLA, and post marketing commitments)
Work effectively with team members and contractors both in person and remotely. Provide direction, support, and corrective action as needed
Have a high level of scientific curiosity and keep informed of technical developments within the industry by attending conferences and reviewing papers thus advocating a culture of continuous improvement
Over seven years of relevant biological process development and manufacturing experience with a strong record of achievement
Hands-on experience with culturing cells, operating microbial fermenters and/or mammalian bioreactors as well as harvesting material using centrifugation, depth filtration and/or TFF
In depth understanding of environmental, nutritional and mechanical factors influencing cell growth, productivity and longevity
Hands-on experience with purification techniques including operation of AKTA and UF/DF systems as well as analytical methodologies (SDS-PAGE, HPLC, spectrophotometry)
In depth understanding of charge and size based separation mechanisms and manipulation of operating conditions for optimal separation of target protein from process and product related impurities
In-depth understanding of primary, secondary and tertiary protein structure and post translational modifications
Knowledge and experience of working with statistical programs (Minitab, JMP) for design and analysis of experiments
Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites
Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD
Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity
Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement
Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost targets
Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics
Experience in defending processes, procedures and investigations during FDA/EMA inspections – experience with preparation for PAI’s and inspection support a strong plus
Demonstrated technical proficiency, scientific creativity, and innovation individually and in collaboration with others
Masters or degree in Science/Chemical Engineering or higher

Fellow Late Phase Downstream Process Development Resume Examples & Samples

Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as principal scientist or equivalent
Recognized expertise in a specific area
Profound literature search skills
Ability to work in and/or lead interdisciplinary and/or cross-cultural teams
Advanced coaching skills

Process Development Associate ADC Resume Examples & Samples

Assists in the process development of some or all of the following: ADC conjugation reactions, ultrafiltration/diafiltration, column chromatography, filtration operations, and pre-formulation studies
Participates in tech transfer activities, including process descriptions and batch-record generation
Prepares components, buffers, and other solutions as needed
Participates in the design and modification of process development protocols
Performs experiments following process development protocols
Composes and presents research data, reports and manuscripts
Researches and implements new methods and technologies to enhance operations
May cross train on various tasks including downstream cGMP manufacturing as needed to support overall success of the ADC group
Embodies Althea’s cultural values and aligns daily interactions with department goals and company culture

Director Process Development Resume Examples & Samples

Manage internal resources and external partners to develop robust commercial lab workflows
Participate in or lead cross-functional teams in planning, developing, validating, and implementing robust and scalable integration solutions for a laboratory developed test product or platform for multiple products
Manage the generation of process documentation, including (as required) operational requirements, process descriptions, technical specifications, process models, and others
Generate and/or review process risk assessments and/or process FMEAs and develop risk mitigation plans
Manage the generation of engineering and user test cases to support equipment the implementation of the workflow
Provide process engineering support to clinical lab operations, product development and the rest of the company
Define and manage the execution of scale-up capacity projects to ensure testing capability meets market demand
Provide technical leadership for timely resolution of complex process issues
Manage documentation to ensure regulatory compliance
Collaborate with other functions, such as non-clinical biostatistics, on designing studies to evaluate method characterization, operational hold times, specification setting and others
Work with Project Management to build development schedules and track progress using a robust development process
Participate in engagements with outside partners as necessary to incorporate their laboratory tests into Genomic Health business workflows
Advice and present options, tradeoffs, recommendations, and plans to senior management on projects and associated product issues and risks
Serve as a subject matter expert on implementing diagnostic testing workflows within Genomic Health, proving expertise in this area to colleagues outside of Engineering
Apply Robust Design / Design for Six Sigma principles to the development of solutions for Genomic Health workflows
An engineering or science degree and at least 15 years of relevant process development experience with complex workflows and products
Experience in molecular biology, and the underlying chemistry of nucleic acid- based assays involving PCR, DNA sequencing, and related methods
Expertise in the design, development, and validation of robust, scalable laboratory processes comprised of integrated automated and manual workflows, utilizing liquid handling robotics, analytical instrumentation, complex reagent sets, and software
Superb written and oral communication skills, and demonstrated excellence in communicating and collaborating with colleagues and customers from a wide variety of scientific, engineering, operational, and regulatory disciplines across the organization at many different levels
Demonstrated ability to effectively lead and participate in cross-functional project teams
Critical thinking skills required to judiciously plan and prioritize project activities for maximum leverage and impact
Demonstrated leadership skills required to align colleagues and stakeholders around a vision and a plan to achieve it, and to execute this plan
Strong and consistent commitment to quality in the development, testing, and implementation of systems to be used in Genomic Health’s laboratory developed tests
Ability to integrate and apply feedback in a professional manner
Experience in the development of laboratory diagnostic tests using automated liquid handlers, qRT-PCR or sequencing
Experience in developing diagnostic test in a highly regulated environment (CLIA, FDA, etc.)

Process Development Manager Resume Examples & Samples

Facilitates tactical planning and execution of new product development, consistent with the R&D Operating System model. Leads cross functional teams in planning sessions, daily project huddles, and structured problem solving
Identifies, implements and drives improvement efforts to reduce new product development cycle time. Analyzes and improves existing work processes, creates new systems to facilitate faster development time, and leads the implementation of these improvements
Functions as a trainer, coach and mentor for the Design for Six Sigma program. Prepares and delivers DFSS curriculum, coaches DFSS certification candidates and provides feedback on formal certification submissions
Provides input and assistance to Formulation Scientists in the development of manufacturing processes for new and reformulated products. Functions as the DFSS / statistical expert for formulation and process development
Provides input and assistance to Operations, Quality Control, Quality Assurance, and Validation Teams with respect to the validation and launch of new and reformulated products
Participates on a variety of cross-functional teams, including project core teams and R&D / Project Management planning teams. Ensures cycle time reduction activities are implemented, consistent with the R&D Operating System model
Writes design state review (DSR) summaries, FMEA reports, critical process parameter analyses and other reports as assigned
Interfaces with professional groups and regulatory agencies, as directed by management
Maintains state-of-the art knowledge with respect to manufacturing technology, process improvement, and performance excellence methodologies by attending seminars, trade shows, conferences and industrial visits; establishes and maintains outside contacts for information exchange regarding manufacturing technologies, theories, and developments
Completes projects within the specified time periods and within applicable cGMPs, GLPs, Standard Operating Procedures, and Controlled Substance Handling Procedures
Thorough knowledge of pharmaceutical manufacturing processes, equipment and testing procedures
Working knowledge of pharmaceutical ingredients including the understanding of chemical and physical properties of active ingredients and excipients
Thorough knowledge of QbD, cGMPs, GLPs, FDA Guidelines, Standard Operating Procedures, Controlled Substance Handling Procedures, and other regulatory requirements governing pharmaceutical manufacturing
Working knowledge of Design For Six Sigma Principles
Ability to complete projects independently with little supervision
Ability to coordinate multiple projects and perform multiple tasks at the same time
Ability to persuade, influence and collaborate with others to achieve common organizational goals. Capable of comfortably interacting with senior leaders
Flexible work schedule for fully utilizing equipment and facility resources
Computer skills with knowledge of Microsoft Office and Minitab programs
Good critical thinking and structured problem solving skills
Must be able to function in a team environment

Fixed Bed Process Development Resume Examples & Samples

Keep in touch with Polymer process units and to be aware of problems faced in the plant
Perform modelling/simulation of polymer reactors
Use the modelling and simulation for route cause analysis and profit improvement opportunities in polymer process units
Perform calculations for design of equipment (Lab/pilot and commercial Scale)
Coordinate with vendors during procurement, installation and commissioning of experimental facilities
Write reports for the work completed
General awareness of polymer processes, Polypropylene, PVC etc
Modeling and simulation of Chemical reactors
Strong fundamentals of chemical engineering and their application to commercial process
Scale up/Scale down strategies for polymer reactors
3 - 9 years in similar field
M.Tech/Ph.D. in Chemical Engineering

R&D Thin Films Process Development Lead Resume Examples & Samples

Managing efforts and setting the strategy for developing thin films material, equipment and process technology for memory products
Providing day-to-day project management and technical advice for your team
Managing the needs of multiple customers to set priorities for your team
Identifying technology gaps and kick off equipment, processes, chemicals and materials exploration projects internally or with external partners
Communicating effectively the films technology status and roadmap with R&D Executive Management and Process Integration teams
Driving continuous process and productivity improvements to meet the needs of PI and manufacturing by actively engaging with equipment development team and suppliers
Collaborating with the Manufacturing Development Engineering team to meet R&D product quality and cycle time goals
Resolving yield and defect issues related to your process area
Working closely with R&D Management, Process Integration and High Volume Manufacturing Sites to regularly align on project priorities, timelines, and needs
Engaging with manufacturing sites, Manufacturing Integration and Central Teams to provide technical direction and maintain alignment between production and R&D
Providing regular feedback to your team members on performance, developing a career plan and mentoring your team members to support their professional development, through Micron’s performance planning and appraisal process
Setting and communicating performance goals for the team, and conducting goal based performance reviews for all team members
Minimum of a Master’s degree in an Engineering, Materials Science, Physics or Chemistry or similar related field. Bachelors + 5 years extensive relevant experience may be considered as a substitute for graduate degree
General understanding of DRAM and NAND memory devices and cell function and critical thin films challenges
At least four years of process development experience at Micron or equivalent experience at another company
Demonstrated ability to lead successful projects
Demonstrated ability to form constructive relationships with partners and customers
Demonstrated ability to be independent driver for results and solutions
Demonstrated problem solving capabilities using structured and data driven approach
Ability to mentor and manage the performance of direct reports
Proven ability to solicit feedback, accept input, and analyze success/failure
Proven team-building skills, the ability to delegate, motivate, and assist direct reports in reaching their goals and ability to solicit feedback, accept input, and analyze success/failure

STC CVD Process Development Senior Engineer Resume Examples & Samples

Develop and optimize unit processes to meet the yield and quality requirements of advanced NAND parts (110s and beyond)
Quantify benefits of innovative process and/or equipment solutions to enable early experimentation and adoption for process margin improvement
Prioritize within Singapore based manufacturing CVD team on the key technology issues that need R&D breakthroughs
Participate with Boise R&D CVD peers on technology choices for the upcoming nodes and able to translate future technology device needs into clear process requirements
Serve as a technical expert within Micron contributing to technical projects for improvements to processes, procedures and equipment
Provide advice and counsel to management on significant technical issues. Leads and initiate innovation projects through patents/technical papers
This position requires communications and collaboration with partners both locally and globally. Strict adherence to Micron Intellectual Property protection policy is a must

Process Development Technologist Resume Examples & Samples

As a member of the Technical Services team at Mylan Dublin Respiratory, partake in process development, process optimization and investigations of dry powder inhalation products
Using statistical assessment, help develop a robust and repeatable manufacturing process, predict and implement optimization
Develop and write protocols and coordinate the execution of development, exhibit and process validation batches
Play a key role in the product technology transfer and manufacture support to allow for successful process validation and commercialization
Capability to become Process and Product Subject Matter Expert responsible for the development and technology transfer of robust manufacturing processes to commercial operations and ongoing product stewardship
Take the lead for various aspects of the Process Development and Manufacture Support, ensuring all deliverables are met as per the plan and facilitating the resolution of any challenges as they occur
Liaise with senior management obtaining support for key deliverables and communicating progress through periodic presentations, report summaries, publishing of meeting minutes for distribution or other selected formats
Ability to set-up appropriate communication channels between functional units at donor and receiving sites to facilitate right first time Technology and Knowledge Transfer
Bachelor in pharmaceutical sciences or chemistry or other applied sciences. MSc and PhD are seen as an advantage
3+ years’ experience within the pharmaceutical sector of formulation development, process development and optimization or technology transfer
Strong technical writing skills with respect to protocol/report writing, batch record and SOP writing. Experience of root cause analysis/investigations and excellent problem solving skills are a surplus
Good team working skills with experience of coordinating teams on different work patterns and scheduling tasks/activities in the area
An understanding of the requirement to meet project and team orientated goals and the ability to create win-win relationships with other functions to meet these goals
The ability to work flexible work patterns to achieve project goals is required
Excellent interpersonal communication skills with the ability to interact effectively at all levels within the organization
Good knowledge of Technology Transfer guidelines and procedures for the transfer of manufacturing process, controls, methods and knowledge from a donor site to a receiving site

Process Development Group Resume Examples & Samples

Having 3 years working experience in RnD and process improvement
Statictics savy
Proficient in English (oral and written)
Leadership & Communication Skills
Integrity and Conviction
Learning capacity

Snr Process Development Engr, Msat Resume Examples & Samples

Degree in Chemical Engineering, Chemistry or a related discipline
0 – 4 years of experience in Biotechnology process development, process support, research or a related manufacturing environment is desirable
Prior hands-on technical experience (in a laboratory or manufacturing environment) is desirable

Process Development Associate / Engineer Resume Examples & Samples

Cultivation of mammalian cells using aseptic technique in bench and pilot scale bioreactors for the production of monoclonal antibodies
Scale-up process evaluation and troubleshooting in support of clinical productions
Detailed data analysis of seed train, production, and quality data in support of process understanding and technology transfer followed by authoring of development reports and process transmittals
Integration of Process Analytical Technology (PAT) for improved cell culture analysis and closed loop control
Active involvement in Technology Transfer Start-Up Teams, which includes technology transfer via written process transmittals and on-site support to our manufacturing facility in Albany, NY during clinical production campaigns
Production of various nonclinical reagents in support of Regeneron’s Research and Development activities

Process Development Technician Resume Examples & Samples

Good communication skills, conveying information both professionally and concisely
Actively champion and promote all safety related policies and programs to ensure colleague engagement and commitment to the benefits of working safe
Support of the development of manufacturing technology and capabilities for new/improved products and processes
Support of efforts to develop and implement technology and practices to reduce contamination, increase productivity and yield and increase utilization of idle equipment
Conduct experiments in lab and full-scale process equipment
Support installation, startup and transfer of new technology
Perform troubleshooting and problem solving
Develop management of change requests, operating procedures logs, etc. and provide training related to technology transfer functions
Document results and generate reports

Senior Channel Process Development Manager Resume Examples & Samples

Leads and has overall responsibility for global channel initiatives with key objective to delivers best in class supply chain Channel performance. Driving process and business improvement to deliver substantial impact for the business
Identifying and implementing transformational initiatives that deliver significant positive differentiators resulting in increased service level and performance with accounts
Ensures that systems and processes are used correctly, driving efficiencies where required
Assess overall performance of supply chain services including collaborative forecasting, customer demand fulfillment, demand availability management, exception management and deployment of new logistics services to customers within the geography
Leads engagement with internal subsidiary stakeholders on improvement initiatives. Focusing on Cost saving and leveraging best practices across all regions and Areas
Bachelor’s degree or equivalent work experience. MBA a plus
Experience delivering system & process improvements across Order / Demand Management functions like Order to Cash (O2C). Or forecasting, customer demand fulfillment, demand availability management, exception management, deployment of new logistics etc
Process Optimization management, or BPR - business process reengineering experience strongly desired

Process Development Manager Resume Examples & Samples

Lead, manage and develop the Process Development team in Monthey
Responsible for assuring that all associates (and contractors) in Process Development- Monthey perform their job functions in conformance with the EHS & QM Policy. Appropriate resources will be deployed, both human and technical, and provide necessary information, training and management systems, to enable the staff to be knowledgeable of, and responsive to, all Policy compliance requirements applicable to their respective job function
Taking Technology results (like new products etc) into production. Ensure that products will have matching manufacturing processes and machines to run these processes
Support product transfers if technology input is required
Optimize manufacturing processes in capability / reliability /capacity/ de-bottlenecking. Aim for step-out rather then incremental improvements
Provide Benchmarking of manufacturing processes, mainly internally between sites, sometimes externally
Perform techno-economic evaluations such as cost calculations
Improving product quality. Respond to product quality complaints. Focus on improvements in consistency and capability
Develop tools & methodology's to achieve the above
Assure that critical success factors for Process Development are captured in KPI's. Use these to drive and continuously improve the performance of the group
Develop knowledge and capabilities within Process Development to support the mid to long term business and manufacturing strategy
Ability to manage large Technical Projects cross-regionally
Coordination of McIntosh-WMO knowledge, good practices and manage specific projects
Manage and develop the Safety Lab Unit to comply with the highest Process Safety standards
Strive for a professionalism and performance driven team by
Having clear job descriptions to clarify roles, responsibilities, and accountability
Help staff to set and align their goals with PD strategy, plans and initiatives
Secure that Process Development is involved and contributing to the Technology ambitions for the future. Be a pro-active partner in the technical continuum
Manage Monthey Process Development budget
Promote and track Programmes developed On Site e.g: 5 S – Kaizen– 6 sigmas– behavioural Safety- OEE/OPE– Step Change
Member of Monthey Site Leadership Team
Developing others
Building teams
Conceptual thinking
Global Vision

STC R&D Wet Process Development Senior Engineer Resume Examples & Samples

Identify disruptive processes early on and work with manufacturing and Boise R&D to identify viable path forward
Initiate and manage experiments to widen process margins as well as to test out manufacturability of next node solutions
Design and implement advanced process monitoring and control methodologies
Leads team or sites or suppliers on complex, multi-disciplinary projects in quality focused meetings, process and yield improvement meetings, cost and productivity improvement meetings
Provides advice and counsel to management on significant technical issues. Leads and initiate innovation projects through patents/technical papers

Head of Downstream Process Development Team Resume Examples & Samples

25%: Leads experimentation and manufacturing support related work including laboratory and pilot scale studies (chromatography and filtration unit operations) to support new process development and optimization. Evaluates new generic platform technologies that can be applied across multiple programs. Leads tech transfer of multiple programs spanning all phases of biopharmaceutical lifecycle, including discussions of scale, equipment design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, troubleshoots problems and supports their operations
25%: Writing, reviewing and approving of data summaries, technical reports, technology transfer packages, regulatory submissions and presentations
25%: Organizational support and cross-functional project team leadership and participation. Advises senior management on goals and project direction
25%: Effectively leads, trains and mentors group of direct reports. Provides guidance on design of experiments, data analysis and derivation of appropriate conclusions. Creates opportunities for the development of direct reports. Recognizes achievements, inspires the team and provides constructive feedback

Enterprise Process Development Group Engineer Resume Examples & Samples

Provide effective guidance & support to manufacturing & engineering for new projects & expansions, including development of business cases
Assess and enable the capabilities of the manufacturing sites in order to enable new product developments
Look for innovative solutions both incremental and breakthrough in the areas of optimization and new technologies Define and published standard key performance metrics for their area in order to discuss these openly, positively & constructively to improve operations through benchmarking on global scale
Coordinate and provide design, start-up’s and optimization of new processes
Provide knowledge, structure and leadership in solving complex operational and quality problems to execute 3d line troubleshooting
Ensure consistent standards are applied across the manufacturing sites in their area of expertise across BU’s to ensure Cargill leverage
Ensure accumulated knowledge & Best practice is appropriately captured, documented shared & implemented through local organizations globally in order to capitalize on Cargill size and global spread
Capture developed Intellectual Capital regarding process technology in order to gain sustainable cost advantage
Ensure external benchmarking & development tracking is in place in area of expertise to avoid missing important industry developments
Function as a key representative and contact to the local and SSE PDG organization. Ensure knowledge is transferred and assist with consistent implementation activities on a divisional basis to support the business model
Assist and support R&D (research and development) and PPD (Product and Process Development) when it concerns product development
Lead R&D and PPD when it concerns process development, doing trials and implementation of concepts regarding new products
Collaborate with other functions (PPD, R&D, Manufacturing, Engineering, Sales) to develop processes for improvement of business performance in general
Provide technology input and leadership as Manufacturing technology leader to PSRM
Education or equivalent experience
Master degree in Engineering/Science based discipline (or equivalent)
At least 5 years experience in relevant field
Extensive knowledge of at least one of the related processes
The ability to work effectively with cross cultural and fuctional teams
Demonstrated ability to understand complex operational, engineering and business activities
Six sigma green or black belt level of approach or comparable experience
Preferably multi-lingual
Network of experts in the field inside and outside Cargill
Able to think and act across boundaries
Demonstrated informal leadership skills
Responsive and result drive
Ability to finalise projects and initiatives through drive and conviction
Commercial mindset
Play to win, engaged, passionate for technology

Process Development Coop Resume Examples & Samples

Develop and scale-up drug product unit operations
Focus on understanding, identifying and optimizing important process parameters
Write technical reports and deliver presentations to project groups
Responsibly handle and provide oversight during processing of DEA control substances
Ability to apply chemical engineering scientific principles to design, execute and interpret experiments
Basic understanding of synthetic organic chemistry

Fellow Late Phase Upstream Process Development Resume Examples & Samples

Successfully demonstrated several years (mini-mum of 5 years) of directly related experience as principal scientist or equivalent
Recognized expertise in USP mammalian cell culture
Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs
Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications
Thorough understanding of development processes in a specific function
Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies
Strong presentation skills and scientific/technical writing skills

Process Development & Innovation Engineer Resume Examples & Samples

Actively participate in full compliance with the site’s Total Safety Process (TSP)
Identify safety concerns and implement countermeasures to correct potential safety issues
Identify areas of improvement on the manufacturing floor and collaborate with R&D scientists and engineers to provide solutions with direct impact in quality and cost
Scout external vendors and technologies and present recommendations for new technologies implementation to management
Develop capital projects (includes developing scope, conducting project safety reviews, generating estimates, serving as project manager)
Participate in the improvement of operating procedures and management of change
Interface with Project Managers to conduct production trials for new processes/products
Collaborate with manufacturing engineers to the development of inline inspection and monitoring system
Interface with the Quality Department to identify actions for quality improvement and implement root-cause analysis, statistical process control (SPC) and other quality initiatives
Communicate results, conclusions and recommendations to internal and external audiences. Keeping others informed of your work (Monthly Reports, Project Reviews, etc.)
Document work with clear, concise via technical reports and complete in a timely fashion
Bachelor/Master of Science/Art – Mechanical, Industrial, Chemical, Optical, Physics or related discipline
3+ years of experience in an R&D, Engineering and/or Operations
Computer Environment: Microsoft: Word, Excel, Power Point
Familiar with Six Sigma Methodology as well as Minitab and/or JMP
Experience/familiar with wet coating application: Gravure and Slot Die
Ability to handle multiple assignments of varying complexity
Strong leadership and interpersonal skills for implementation of cross-functional process improvements
Strong background in analytical and quantitative skills for problem solving of large/complex problems and proven ability in decision making
Familiar with Roll to Roll Web Technology a plus but not required
Familiar with optical metrology
Good written, listening and verbal communication skills
Be a team player in a team environment
Be a self-starter and a self-motivator
Have the ability to respond to call outs and flexibility to work overtime and extended hours during week days (including weekends and holidays if needed)
Have a desire to make a measurable positive impact to plant performance and profitability
Have a desire to obtain hands on experience in R&D and plant operating environment

Co-op Process Development Resume Examples & Samples

Enrolled in a Bachelor degree program in in engineering or technical discipline or equivalent
0-3 years of experience in a laboratory or manufacturing environment
Rudimentary knowledge of statistical, analytical and problem solving methods
Good organizational and multi-task skills required
Solid writing skills to record reports documenting experiment results
Must pass respirator fitness test
Must be able to lift 40 lbs
Flexible schedule for experiments and development projects as required
Strong desire to work in a positive, constructive, high energy, start-up environment

Process Development Associate Resume Examples & Samples

Prepares components, media, buffers, and other solutions as needed
Accurately records procedures and results in lab notebooks
Responsible for routine maintenance of lab equipment
Trains new personnel in process development procedures
May cross train on various tasks including downstream cGMP manufacturing as needed to support overall success of the Biologics group

Construction Specialist, Process Development Resume Examples & Samples

You will be responsible for the development and implementation of standard documentation for Offshore construction activities
Internal process mapping related to preassembly and construction activities as well as implementation of new processes
You will carry out scenario analyses and evaluate on construction related options
Support and guide the project teams with standardized construction solutions

Temporary Process Development Technician Resume Examples & Samples

Deliver assigned project tasks. Assist in the setup of process trains and process flows
Manufacture experimental and GMP batches at various scales
Cleaning of equipment and rooms in compliance with housekeeping standards
Adherence to and comply with all company and departmental cGMP and safety procedures at all times. All work to be carried out in a safe and compliant manner
Undertake all required training in a conscientious, enthusiastic and timely manner
Accurate and legible completion of paperwork. Ensure all documentation is completed in a compliant manner. Participate in the update of batch paperwork’s to ensure they are in line with current procedures
Participate in the update of SOP’s

Undergrad Co-op-process Development Resume Examples & Samples

Perform advanced statistical analysis to support multivariate analysis platform (Digital Development Program)
Basic problem solving skills
Ability to interact constructively with peers

Director, Process Development Resume Examples & Samples

Will work in close collaboration with plant management, R&D, engineering and commercial groups
Supervise a team of technical personnel with a diverse skill set
Lead cross-functional teams and get results while balancing the priorities and needs of multiple projects

Head of OPS Process Development Resume Examples & Samples

Actively manage, support and develop the Control Loop Owners and their teams in order to continuously deliver high yield and excellent results for the b123, b221, Classical Electrodes, Reagents and Quality control/ releases
Foster an environment with strong focus on continuously improvement of processes and a well-structured problem solving approach
Implementation of BG&E Operations / department strategy in the team (definition of team objectives)
Ensure strong interfaces with the other Team Leads with-in the BGE Engineering Department; Process Engineering, Process Qualification and Validation
Ensure strong interfaces and collaboration with sensor and reagent manufacturing as well as between product life cycle teams, R&D, quality assurance as well as external partners
Performance and Compensation management, individual development and recruitment

Process Development Manager Resume Examples & Samples

7+ years of Operations or Engineering experience
BS or BA Degree in Business or Engineering required; Master’s Degree preferred
Ability to accurately assess key business metrics and situations from a “general manager’s” point of view
Ability to design, develop, and implement a DBS roadmap for an operating business
Mastery of a variety of DBS tools
Superior training skills and adult learning theory
Superior consulting/influencing skills
Hands-on experience implementing DBS (or TPS) in a line management role
Exposure to and participation in a wide variety of training environments
Good writing and administrative skills, including computer skills (word processing, graphics, spreadsheet, etc.)
Teamwork - must be able to lead a team(s) of employees from multiple disciplines and/or companies
Ability to influence others - must be able to inform, convince, and persuade others to action on key initiatives
Standard Work advocate – in their own work habits as well as their interaction with others, consistently strives for establishment of standard work
Sales Familiarity – must be able to relate to the realities of what field sales associates deal with and incorporate that into their process development work
Communication—must be able to effectively communicate in both written and verbal forms

Snr Process Development Engr, Msat Resume Examples & Samples

Work with other MSAT team members, technical experts from Lonza’s customer companies and with Lonza Manufacturing (MFG), Quality Assurance (QA), Quality Control(QC), and other departments on the technology transfer
Process Support: Lead the preparation, execution and post-campaign activities for purification stages of the customer’s manufacturing processes at Lonza Singapore production facility. Become proficient with all processes in the facility and develop ability to support/lead activities for multiple cell lines. Monitor processes on a regular basis to further understanding of process behaviour and prospectively identify process issues. Develop ability to generalize issues across cell lines
Write planned deviations, change requests and drive to implementation as needed
Identify training needs and, design and prepare a variety of training materials for MFG operators on purification process batch records. Work with MFG to update process records to enable robust manufacturing operations
Support plant start-up and pilot/commercial runs and perform technical investigations and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for purification operations
Actively engage customer technical experts as necessary to progress technology transfer or process support activities
Keep current appropriate databases with MFG cell culture process data and analyze to monitor run to run consistency of operations
Any other duties as assigned by your Supervisor/Manager
Prior hands-on experience in cell culture experimental technique and equipment

Product / Process Development Manager Resume Examples & Samples

Work with Technology group, support new process and product development by serving as the Airgas Healthcare representative on the project
Ensure all designs are robust and easily transferred to Airgas Healthcare operators and manufacturing
Serve as cGMP (current Good Manufacturing Practices) consultant; all systems must be able to be validated and able to operate in a cGMP environment
Lead documentation effort, including sub-tasking, writing, reviewing, and approving all aspects of process documentation, through raw material specifications and test procedures to manufacturing procedures
Interface with customers on process technical issues, in support of Technology personnel
Serve as key member of new product/process design team for new chemical development programs. Identify, design, justify, develop, implement, validate, and train operators in manufacturing process improvements for fluorinated product operations
Using operating knowledge, user feedback, and technical input from the Technology Group, identify opportunities for process improvement that will improve safety, costs, yields, or capacity
Design the improvements, and estimate costs. Determine if improvements are justified, and if so, lead efforts in development, implementation, validation, and training of operators in their use
Responsible for product management
Provide product pricing for proposals and quotes
Monitor product profitability and lead efficiency projects to reduce costs
Develop competitive knowledge regarding product offerings and market price of products
Lead and participate in troubleshooting efforts of operational issues with fluorinated processes
Interface with the FDA and other governmental agencies as they relate to fluorinated products technical issues
Support new business development of products by serving as technical representative
When new opportunities arise, liaison with technical personnel to investigate the possibility of the product, and the required business development plan
Lead resolution of technical issues as they relate to proposals and contracts
Maintain a clean, organized, and safe environment
Complete all training activities successfully and on time
Manufacturing experience in medical device or pharmaceutical environment required
Ability to maintain environment of rapid development
Basic project financial ability, including ability to layout payback timelines
CAD/mechanical drawing experience preferred
Computer skills, including knowledge of operating systems, word processing, spreadsheets, and project management software
Demonstrated skills with documentation and technical writing
Detail oriented, with strong organizational skills

Technologist Process Development Resume Examples & Samples

Perform new ion beam deposition and milling tool qualification and transferring to production
Work closely with advanced reader process development group to transfer new ion mill and deposition processes into production
Responsible for the maintenance and continued improvement of the junction mill and soft bias process Cpk

Process Development Technician Resume Examples & Samples

Perform motor validation and acoustic tests, focusing on a thorough and consistent approach
Manufacture high quality assembly fixtures using workshop machinery as required
Support others in preparing and implementing motors into testing facilities
Adhere to safe working practices and lab rules, challenging others when required
Execute duties which support the department by scheduled maintenance, equipment checks, housekeeping
Undertaking peer reviews of others work providing constructive feedback informally or through reviews participation
Autonomously drive programs of continuous improvement activities demonstrating a business case where required
Take responsibility for a support function within the lab e.g. COSHH, Lab deputy, Equipment WI’s etc
Provide ad-hoc cover for the Motors Build Supervisor
Ability to interpret and interrogate engineering drawings and documentation,
Detailed experience of complex assembly processes
Practical and methodical approach to problem solving with a keen focus on attention to detail and timescales
The ability to continuously improve the lab and its technology
Excellent verbal and written communication to convey information in an appropriate and concise manner

Process Development Leader Resume Examples & Samples

Follow all forging instruction for the manufacturing of ATI forgings
Sets up dies in hammer, directing crew positioning and aligning of dies
Operates hammer throttle, controlling the force of hammer flow to manufacturer pre-forming's or forgings, to our customers specification
Checks forgings for visual defects

Tendering Process Development Leader Resume Examples & Samples

Develop and deploy best practice, process and standard work across the Tendering organization
Support the transformation of our processes and daily management initiatives by ensuring strategies are implemented and principles/practices/tools are incorporated in the culture and processes under transformation
Ensure the tendering team members are using standard work to independently review customer specifications and make appropriate equipment selections
Conduct regular check-in’s to analyze current state including understanding customer satisfaction, both internally and externally
Develop processes to provide tendering lead times that maximize the business’ competitive position while reflecting the business’ ability to deliver
Lead and support process improvement activities within tendering and interdependent functions

Process Development Resume Examples & Samples

BSc or MSc and/or PhD in Engineering or Science related discipline
Experience in biological manufacturing processes and or technology
Experience of technology transfer, establishment, and/or qualification in a GP biopharmaceutical, instrument, or medical device industry setting
Experience with process/analytical/technology development using principles of design for manufacturability, Quality by Design (QbD) in the bio therapeutics, medical device, instrument or cell therapy industries
BSc or MSc and/or PhD in Chemical, Bio/Biochemical, Automation/, Systems Engineering or other engineering related discipline
Experience in the automation of cell therapy processing and/or analytics unit operations
Experience of manufacturing using single use systems
Experience in the design and/or use of microfluidic devices for cell therapy processing and/or analytics unit operations
Expertise in the use of statistical experimental design, data analysis and development of highly capable manufacturing processes
Excellent understanding and experience in the use of current Good Manufacturing Practices (cGMP)
LI GSK*

Process Development Manager Resume Examples & Samples

To manage and provide support in troubleshooting existing problem formulations and suggest suitable improvements through the Process development team
To manage and assist in the transfer and scale up of products from Mylan R&D/Pilot Plant into the manufacturing facility
To supervise the manufacture of scale-up, stability and clinical batches within the pilot plant/production facilities in support of any submission processes
To drive the transfer of products from other manufacturing sites world wide into the manufacturing department
To oversee and assist in the transfer of products from site to other manufacturing sites
To coordinate all activities to maintain the process and cleaning validation programs. To coordinate and assist in the timely execution of Trial and Validation batches and ensure that deadlines are met and all correct sampling is carried out
To coordinate and assist in the timely sourcing of production equipment/tooling and materials (excipients and API) required for new products or as a result of process improvement initiatives
To coordinate and manage the activities of the relevant CFTs to drive COGs and process improvement projects in line with site demands and to use solid problem solving methodolgies to identify CAPAs.writing articulate and accurate technical reports suitable for presenting to Health authority auditors
Support the implementation of the Operational Excellence Program on the site by identifying, leading and implementing improvements
To set appropriate objectives for the team in line with company and global needs and ensure appropriate training of all staff to meet competencies necessary to execute their roles effectively and effciently
To manage a CFT for the implementation the API Second sourcing plan
To ensure that high standards of cGMP/cGLP are maintained at all times
To adhere to all company and legislative health, safety and environmental requirements
To represent the site Tech Services group during Health Authority audits
Support and Implement at department level all global EHS programmes and initiatives eg. Incident prevention opportunity
To work with the Global regulatory groups in assessing the Regulatory requirements for submissions and to provide to provide the relevant data, reports and responses in reply to Health Authority questions
To undertake any additional tasks as assigned by the Technical Development Director
Bachelor Degree in Science or Pharmacy.Master's degree in Science or Pharmacy a distinct advantage
Excellent knowledge of Oral solid dosage forms is a must with a minimum of 7 years relevant experience
This roles requires a combination of excellent Scientific knowhow relevant to Solid Oral dose formulations coupled with a good knowledge of the regulatory requirements of EU,APAC and US reg authorities as well as excellent project management and people leadership skills
Thorough knowledge of Current Regulatory requirements with respect Process Validation, Validation life cycle and problem solving is a must
Experience in leading and managing small, expert teams
Knowledge of Pharmaceutics and Statistical analysis and Formulation of Pharmaceutical Oral solid dosage forms

Senior Group Leader Global Beverages Process Development Resume Examples & Samples

Global Beverage Process Strategy – Provides thought leadership and translates the overall global commercial and supply chain strategies into a robust beverages (PB and CB) process development programme. Insures connectivity and integration with the ISC strategy as an active member of the Beverages ISC network
New Process Technology – Aggressively pursues the discovery, development and deployment of new process technologies for a step change in beverages innovation and efficiency. Constructs a pipeline of process technology TIP’s, and collaborates with the Beverages Ingredients Platform team, Global Research and external partners to leverage scientific insights and learnings to create new processing methods. Secures sustainable competitive advantage through appropriate protection of intellectual property
Superior Execution – Guides the team to successfully commercialize global platforms, delivers new processing systems (e.g. Lines of the Future), and identifies, follows IIM and is accountable for the Consumer-Centric Conversion pillar of MDLZ Consumer Inspired Quality. Ensures best practices in Beverages unit operations across the network of Beverages factories around the world
Global Process Development Community – Fosters a culture of collaboration across the Beverage process development global community, insures WOW are consistently applied and, identifies resource and capability gaps, and builds global talent. Enhances process development capabilities at Mondelez by co-creating and delivering the agenda of the Global Process CoP with the other category leaders
Beverage (PB) Pilot Plant (Curitiba) – Delivers superior PB scale up and process testing through a robust, efficient and safe pilot plant operation consisting of many factory-scale systems. Insures collaboration with the CB pilot plant located in Thane to share best practices and learnings, and with other PB labs
This Candidate will serve as a Senior Group Leader for the Global Beverages Process Development Team; independently manages 4-5 engineers and influences cross-functional project teams
The candidate will have responsibilities for the all elements of Consumer-Centric Conversion of our Consumer Inspired Quality Strategy
This person will also serve as a Senior Technical resource for the Beverage RDQ team and the plants
The person should have a key understanding of the use of statistical tools to drive process optimization and can coach others
Product Development
Quality (CTPs, CQV, HACCP, etc)
Statistics

Unit Process Development Specialist Resume Examples & Samples

Development of Die and/or Lid Attach processes for new packages or packaging technologies
Introduce new processes and concepts to manufacturing and ensure high manufacturability in mass production
Supports process, material and equipment roadmapping
Implements and supports in full compliance defined policies and Quality standards during development and ensures lessons learned are passed on to operations during product ramp up

Process Development Manager Resume Examples & Samples

Execute the Process Development Engineering strategy in support of the overall R&D strategy and international business initiatives
Develop and implement new processes from initial concept through implementation. Independently manage assigned projects coordinating closely with international business partners, Marketing, Sales, Supply Chain, Finance, Legal and the cross functional R&D team
Develop thorough and robust procedures on assigned projects
Accountable for assigned projects including prompt and detailed follow through and documentation in a systematic and methodical manner
Work closely with cross functional teams in Manufacturing Engineering, Packaging Engineering, Marketing and other business partners
Drive the pro-active uncovering and development of new “out-of-the box” process ideas to grow the business leveraging on consumer insights, market trends, industry practices and innovative technology
Provide technical expertise for international initiatives including cost savings, process, manufacturing, packaging, and quality
Perform a hands-on and systematic approach to project work keeping an eye on the end game result
Participate in pipeline reviews and assist in driving pipeline development
Effectively communicate to an international team from manufacturing floor to corporate executives
Ability to travel up to 60% of the time

Manager.r&d-product & Process Development Resume Examples & Samples

Manage a team whose core objective is to drive product and process development and scale up for FCC catalyst systems, including a manufacturing pilot plant
Drive catalyst technology development and stewardship
Lead efforts to scale up catalyst preparation processes from pilot plant to the manufacturing plant
Provide technical mentorship, coaching and developmental opportunities for team
Lead/ Manage product and process development project teams
Evaluate, define and steer research projects as needed
Lead pilot plant efforts to increase and improve capabilities and tools to support process research, including CAPEX management
Oversee plant support and troubleshooting requests

Process Engineer New Process Development Resume Examples & Samples

Managing of the new process projects concerning rubber, plastic or aluminum from initial idea till prove of concept to support all our existing business segments or beyond. This includes taking the lead of project teams, creating and following up on time lines and reporting about the project status to different parties
Developing new processes with internal and external stakeholders to support the current business
Assisting of the implementation teams and verification of the defined process specifications
Acting as an expert with regards to new processes

Manager Aftermarket Systems & Process Development Resume Examples & Samples

Understand the short, medium and long-term goals, and the system and process needs of assigned business areas. Identify system and/or process opportunities, determine alternative solutions, and make recommendations to support these goals
Review and ensure documentation of current organizational processes, systems and structure within the assigned areas. Identify and drive change opportunities that will measurably enhance the overall service levels provided to our customers according to established key performance indicators
Work with the business to develop and support business cases for recommended changes
Benchmark with other business areas outside of Truck, e.g. Volvo Construction Equipment, Bus and Penta on Best Practices. Also benchmark outside the Volvo Group
Monitor KPI’s and SLA’s to ensure processes and systems are aligning to stated goals. Responsible for reporting on overall processes and system KPI’s
Actively contribute to the development of process and system roadmaps and activity planning for the assigned areas
Understand and leverage the global process and IT organization and decision making structure to prioritize and effectively advance improvement opportunities
Working with peers in a global environment, develop best practices that will ensure established processes support a customer-focused, “Ease of Doing Business” philosophy with our fleets and dealers
Strongly represent the Volvo and Mack Trucks North America interests in global project teams where required while also considering the global needs of the Volvo Group
Represent North America in assigned steering committees and workgroups to insure business needs and requirements are fulfilled
Drive local continuous improvement and enhancement project activities related to area of responsibility
Fulfil all responsibilities and duties related to ownership of assigned local systems
Build and maintain a strong performing team through providing leadership, appropriate delegation, coaching and training of direct reports
Bachelor’s Degree in a related field or equivalent work experience in the transportation industry
Master’s Degree or MBA in related field is a strong merit
7+ years leadership or project management experience
5+ years progressive experience in the automotive industry is required, preferably with heavy truck knowledge
5+ years working with aftermarket parts and service systems and processes
Strong merit if experience from the field, working at dealers or fleets
Deep understanding of North America Aftermarket operations, process and systems
Experience working in a multi-cultural environment
Experience working with quality tools driving successful continuous improvements in systems and processes
Thorough knowledge of solution and process methodologies
Thorough knowledge of Dealers’ and Fleets’ business and Management Systems, understanding customers’ needs
Basic knowledge of financial/accounting principles

Process Development Associate / Engineer Resume Examples & Samples

Collaborate with users (process development engineers), system administrators, vendors, and IT organization to develop applications. Strong communication skills required
Create and maintain documentation on procedures, development, and coding. Also create training documentation for end users
Proficiency in Javascript required
Performs other duties as assigned, such as

Engineer, New Process Development Resume Examples & Samples

Assignments have clear and specified objectives and require the investigation of a limited number of variables
Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives
Supervisor screens assignments for unusual or difficult problems and reviews techniques and procedures to be applied on non-routine work
Receives general direction on new aspects of assignments
Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents
Assignments usually include one or more of the following
While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to risk of electrical shock
Will be required to work in a clean-room environment and will need to wear special garments
A Bachelor’s of Science degree (BSEE preferred) in a relevant discipline and a minimum of two (2) years of related engineering experience is required
Experience in the medical device industry would be an asset
Electronics engineering experience is preferred
PLC Programming experience is preferred
Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques. required
Basic English communication skills, written and oral. required
Knowledge of drafting software systems such as AutoCAD and Solidworks (or equivalent) is an asset
Ability to read and interpret engineering drawing required
This position is located in Irwindale CA and may require up to 15% travel internationally/domestically

Process Development Specialist Resume Examples & Samples

Act as the first point of contact within the Process Development Team for data gathering, troubleshooting, and problem solving
Assist Process Development Engineers with the development, implementation, and improvement of business processes and policies needed for nonconforming hardware management, manufacturing and assembly, product traceability, rocket reusability and maintenance, and other critical business/production systems
Assist with the development of business use cases and software requirements for improvements to our Enterprise Resource Planning (ERP) system
Test new ERP system features to ensure they meet documented requirements and business need
Assist with training and communication during major process changes
Draft new and updated procedures that dictate policy and process requirements
Collaborate across disciplines including Engineering, Production, Test, Launch, Mission Operations, ERP, Supply Chain, Mission Management, Customer Contracts, and Management to ensure efficiency and consistency across the organization
At least 2 years of experience in a manufacturing environment directly supporting Quality or Production
Knowledge of database structures and SQL
Experience supporting production of complex electro-mechanical systems in high volume work centers and/or during production ramp-up
Knowledge of lean and quality tools such as Process Mapping, Six Sigma, Root Cause Analysis and Corrective Action, Advanced Product Quality Planning (APQP), Metrology, Process Failure Mode and Effects Analysis (PFMEA), Control Plans, and various problem solving approaches
Dedicated to adopting a Lean approach to quality without compromising safety or reliability

Process Development Manager Resume Examples & Samples

Manage projects from front to end
Projects include but not limited to non-merchandise & merchandise related, brand launches, cross functional initiatives, and one off projects
Collect and analyze across the company for streamlined communication and efficient execution
Act as a liaison with inter-company departments (i.e. Studio, Accounting, Buying, Engineering, Warehouse, etc.) and disseminate appropriate information to cross functional teams to meet goals and deadlines
Produce and analyze reports that measure and quantify projects that focus on business needs
Maintain project management software/database that provides live status to corporate partners
Be mindful of business needs to increase sales with each project
Partner with internal and external teams and vendors to successfully execute projects
Proactively resolve and communicate scheduling conflicts/changes that may affect production schedules
Associate or Bachelor’s degree in Business, administration or a similar field
3-5 years of experience in Project Planning, Analysis, or a similar role
Must be proficient in Microsoft Office, with knowledge of formulas in Excel
Retail, Ecommerce, Accounting, Logistics experience is a plus

Co-op Process Development Resume Examples & Samples

Develop and scale-up drug product unit operations by applying fundamental chemical engineering principles with focus on defining/executing key experiments to understand, optimize and identify important process parameters
Ability to apply scientific principles to design, execute and interpret experiments
Basic understanding of material science

Process Development Assistant Resume Examples & Samples

Acquires knowledge and skills to perform a range of upstream processes and analytics
May participate in the design and modification of Process Development protocols
Reviews and updates process development related protocols and SOPs
Maintains cGMP environment and personal cGMP training requirements
Responsible for maintaining PD lab supplies inventory and ordering of raw materials
Embodies Althea’s cultural values and aligns daily actions with department goals and company culture

Color Process Development Technologist Resume Examples & Samples

To plan, implement, evaluate and report on experimental programmes in order to develop new technology platforms for the Color Pigments business
Develop laboratory processes, methods and tests in order to measure the performance of new and existing Color Pigments products and processes
Train and assist colleagues in the area of own technical expertise in order that they can clearly specify their development programmes
Maintain laboratory instrumentation, equipment and systems so that they are safe, optimised and available for use
To contribute information, know-how and ideas to improve the efficiency and effectiveness of research and development programmes
To improve personal skills, capability and knowledge in order to maximise contribution to meeting the needs of the business
To carry out all duties at all times to be in compliance with all Huntsman Corporate EHS, Product Stewardship, SOX and Business Conduct policies and guidelines
Be educated to at least a BTEC HNC (and preferably a Degree) level in Chemistry, Physics, Materials Science or other related science subject
Have experience planning, implementing and evaluating process development at the laboratory scale
Experience in the chemical industry and with external vendors would be desirable
Experience of progressing development projects at pilot and plant scale
Knowledge of pigment science

Color Process Development Technologist Resume Examples & Samples

Plan and implement on experimental programmes in order to develop new technology platforms for the Color Pigments business
Contribute information, know-how and ideas to improve the efficiency and effectiveness of research and development programmes
Improve personal skills, capability and knowledge in order to maximise contribution to meeting the needs of the business
Carry out all duties at all times to be in compliance with all Huntsman Corporate EHS, Product Stewardship, SOX and Business Conduct policies and guidelines
Be educated to a minimum of a BTEC HNC (and preferably a Degree) in Chemistry, Physics, Materials Science or other related science subject
Experience planning, implementing and evaluating process development at the laboratory scale
Experience in the chemical industry and with external vendors

Films Process Development Senior Engineer Resume Examples & Samples

Prioritize within Singapore based manufacturing CVD/Diffusion team on the key technology issues that need R&D breakthroughs
Integrate and troubleshoot processes as part of cross-functional teams driving yield and quality improvement
Participate with Boise R&D CVD/Diffusion peers on technology choices for the upcoming nodes and able to translate future technology device needs into clear process requirements
Process development will include performing fundamental research, hardware evaluations, as well as testing processes for novel applications and generating intellectual property relevant to Micron
Lead team or sites or suppliers on complex, multi-disciplinary projects in quality focused meetings, process and yield improvement meetings, cost and productivity improvement meetings

Process Development Associate Resume Examples & Samples

Uses knowledge and skills to perform a range of downstream processes, including column chromatography and various forms of filtration
Trains others to perform functional activities and operate equipment
Troubleshoots purification processes that are semi-complex
Researches and implements of new methods and technologies to enhance operations

Director, Upstream Process Development Resume Examples & Samples

Manages the Upstream Development department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems
Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate
Directs the development of scalable processes, to support optimal expression and product quality attributes for both antibodies and recombinant proteins
Responsible for the execution of production batches and supporting manufacturing up to 2 x2000L scale in Single Use Bioreactors
Identifies, evaluates and executes on process improvements to increase existing capabilities
Ensures strong interaction with multiple groups to facilitate appropriate resource allocation and scheduling of signed projects
Acts as technical expert to support technology transfer, facility fit, deviations and root cause investigations
Experience with mammalian upstream process development both at the small to intermediate scale, as well as cGMP biologics production
Proven process and media optimization experience utilizing DoE
Prior experience in process scaling and supporting technology transfer
Strong knowledge of state of the art methods, processes and equipment
Experience writing and revising standard operating procedures and batch production records
Experience with Ambr miniature bioreactor systems is preferred
Experience in process characterization and small scale modeling is a plus
Experience in BPR and SOP generation, review and documentation review
Experience in supporting the investigation of deviations, OOS and CAPAs
Experience in supervising a technical team
Preferred strong understanding of cell line creation and cell line development

R&D Process Development Intern Resume Examples & Samples

Performs purification and required testing in accordance with CSL/R&D methods for the analysis of Intermediates, raw material and in-process samples
Maintains accurate, complete, legible and concurrent records of work performed and enters results in the laboratory notebook
Demonstrates the ability and willingness to follow schedules and meet deadlines
Reviews test data/results for reporting and documentation accuracy
Communicates aberrant results to laboratory supervision immediately
Rapidly gains an awareness of cGMP and GLP and maintains compliance with these regulations
Other duties as assigned by Laboratory Management and/or Sr. Scientist

Intern, Fermentation Process Development Resume Examples & Samples

Partake in design and execution of well-defined experiments
Make detailed observations and provide quantitative analysis of data
Follow written procedures, noting when they need updating; may assist in rewriting procedures
Participate with others in evaluations of methods or technologies
Notebook keeping, compilation of data and interpretation into power point presentations
Present finding to internal groups

Process Development / Control Specialist Resume Examples & Samples

Serve as the primary contact in USGS for all service-level communications with the USGS network branches
Conduct process mapping and coordinate the analysis of operational procedures/manuals; recommend changes where necessary
Work closely and objectively with other department personnel to obtain system/process data in support of consolidated performance development
Administer comprehensive efficiency studies to ensure maximized utilization of all resources; identify process flaws that result in poor service and/or products
Ensure that the periodic reports prepared by Plans and Controls personnel accurately reflect the department’s objectives
Assure that branches are providing acceptable levels of service, working with CSR groups
Conduct Inter-Company Charges (BTC) analysis, and report irregularities and other findings
Travel to branch locations to conduct inquiries, analysis and audits
Perform other duties as assigned or necessary
Minimum of 3 years data analysis experience and/or developing and measuring operational processes
Minimum of 2 years experience with MS Office suite with a demonstrated expertise in Excel
Experience performing process anlalytics
Bachelor’s degree in business or related field
Ability to initiate activities independently, learn and achieve results
Objective observation and investigative skills

Associate Director, Process Development Resume Examples & Samples

Lead a team of scientists and engineers to develop scalable, clinically translatable drug product formulations and production processes for new clinical candidates for Moderna’s growing preclinical pipeline
Develop and implement high throughput processes for formulation of drug product; integrate with high throughput analytical platform to provide a step change in capacity for formulation capacity and drive critical CMC decisions with a deep database of formulation and process information
Using risk-based approaches and a deep understanding of chemistry and engineering principles, design and conduct experiments to identify and optimize critical process parameters and characterize late stage drug product manufacturing processes
Develop and implement scale models of clinical and commercial processes and execute designed experiments to identify and control CPPs
Identify engineering solutions, including process analytical technologies, which lead to robust process control strategies
Design and conduct experimentation to investigate the impact of raw materials and formulation parameters on drug product processes
Provide technical support to resolve scale-up and manufacturing issues, develop solutions
PhD in Chemical Engineering, Chemistry or closely related field with at least 6 years, or BS/MS with 10 - 15 years, of pharmaceutical or biopharmaceutical industry experience in development of manufacturing processes for biologics or other complex pharmaceutical drug products
Significant leadership experience with design and optimization of drug product manufacturing processes, including a track record of translating processes between preclinical and clinical development. Mastery of phase-appropriate development practices
Extensive experience with biotechnology unit operations related to drug product manufacture for complex, and ideally nanoparticle drug products
Mastery of current industry standards for Quality by Design, including linking raw material attributes, formulation and process parameters to product Critical Quality Attributes (CQAs) through designed experiments, development of risk assessments and control strategies for drug product processes
Experience building, leading and managing high-performing technical teams including objective setting, project management, goal tracking and progress communication to management
Innovative scientist with ability to think critically and solve problems in laboratory and manufacturing settings
Experience with scale up and scale down models for novel processes
Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges
Experience with analytical tools for the characterization of drug product processes and products, particularly nanoparticle products
Experience working with commercial manufacturing organizations
Strong familiarity with cGMP, ICH and regulatory guidelines as they relate to risk management and pharmaceutical development

Process Development Specialist Resume Examples & Samples

Bachelor’s Degree AND proven knowledge (such as successful completion of a college/university course in the discipline(s) listed here) of basic chemistry, including stoichiometry, lab practices, basic thermodynamics
Two years or more of prior experience in chemical/pharmaceutical formulation and adjustments preferred
4-6 years of manufacturing/production (lab) experience
Strong analytical, oral communication, and technical writing abilities
Experience with Oracle e-Business Manufacturing software preferred
Ability to lift up to 30 lbs
Ability to stand for long periods of time (8 hours per day)
Good manual dexterity
Loud production environment if required
Working with exposure to bulk powders, organic and inorganic chemicals

Senior Manager Analytical Process Development Resume Examples & Samples

Oversee analytical activities for the R&D and JSC portfolio at CROs located in China (primarily Wuxi, Pharmaron, but not limited to these CROs)
Provide analytical technical guidance and trouble-shooting support to analytical teams in CRO and other external partners. Review technical documents (protocols/reports) from CRO to ensure GMP compliance
Ensure cGMP compliance in all aspects of activities performed at CROs, where relevant
Track performance and provide reports on metrics to Management
Seek creative approaches to improve the accuracy, reliability, flexibility and productivity of the analytical development activities in China
Broad and strong scientific analytical chemistry knowledge in the CMC field, which includes but not limited to analytical method development and validation, GMP release testing, stability study for both API and Drug Product
Strong interpersonal skills to effectively communicate with external sites and various internal and external functional areas
Good understanding of global Regulatory requirements and ability to respond as to authority questions
Ability to prioritize and balance compliance with business needs
Experience of microbial testing is a plus

Process Development Technician Resume Examples & Samples

Cell Culture and Fermentation Processes
Microbial Production Processes
Bioreactor Preparations
Media Prep & Filtering
Mammalian & Microbial Bioreactors
ELISA assay development
Vial Thawing & Cell Freezing
Single Cell Cloning
Stable Pool Generation

Process Development Engineering Manager Resume Examples & Samples

Provides guidance to perform process design and development activities, to insure manufacturability using DFM principles and an overall focus on achieving appropriate process capability, line flow, efficiency, and effective methods for inspection and control
Serve as primary contact and lead person to divisions for process development and manufacturing processes for New Product Development projects manufactured in the Spencer facility. Coordinate with R&D, Marketing and Manufacturing functions to plan future projects and manage current projects ensuring that inputs from both customers are understood and captured in process design
All work will be performed as part of a matrix product development team. Excellent communications skills are required at all levels, both up and down the chain of command
Must comply with necessary regulatory and quality requirements, ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards
Drives functional excellence initiatives, delivers high quality functional deliverables, and ensures technical excellence for product/process and technical development
Coaches other in the appropriate application of product/process development and design related activities and standards
Influences, guides, and manages internal/external resources to achieve critical program goals
Aligns resources and assures cross-divisional support identify opportunities for improvement within the existing processes & systems
Provides significant guidance and approval regarding technical strategies and approaches
Develops and monitors department budgets
Determines appropriate staff levels, schedules and resources
Coordinates sessions with the project managers/core team leaders to look for opportunities for staff to learn about new initiatives or volunteer on new projects
Drives the development of department/functional tools and methodologies
Determines project staff assignments and schedules work to meet completion dates and deliverables
Establishes cross-functional team relationships
Provides an overview of the function and role of his/her group, technical skill sets, to other groups and/or divisions
Works cross-functionally in identifying and resolving technical issues
Drives and evaluates project and department progress, technical development plans and results
Establish and support a work environment of continuous improvement that supports BSC�s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented

Degree Internship for Technology Unit Process Development Resume Examples & Samples

Infineon Kulim [IFKM] would like to extend an invitation to Malaysian students who are in their Final Year studies to undergo the Industrial Trainee with the company
The objective of this program is to provide an opportunity for the students to have an exposure to the wafer-fabrication working environment
The selected candidates shall also be exposed to the wafer fabrication technology and gained knowledge on the industrial practices and required competencies

Process Development Biologics Engineer Resume Examples & Samples

Support a late stage protein drug product process development group in process characterization studies for unit operations including: freeze/thaw, mixing, filling and stoppering
Apply fundamental engineering principles in identifying and resolving issues related to the manufacturing of biopharmaceuticals
Design and perform bench-scale studies for the physical characterization of drug substances and drug products
Examine individual unit operations and optimize processes, assessing the impact on product quality from different stages of the manufacturing process
Evaluate the impact of process improvements or changes in equipment, scale, and raw materials on drug product manufacturing
Support the aseptic filling process for commercial drug products
Author and data verify documentation, technical reports, technical assessments, GMP documentation, and regulatory filings
A strong understanding in chemical engineering principles including thermodynamics, sheer stress, fluid mechanics, and the resulting impact of each on protein drug product quality
Ability to maintain accurate records and follow detailed procedures is critical
Strong computer and organizational skills, scientific (both in the lab and in data analysis),
Excellent project management skills, multi-tasking, and ability to elevate relevant issues to project lead and line-management
Ability to work independently and as part of a team with internal and external clients
Ability to learn new techniques and concepts independently and by recruiting the expertise of others
Experience with drug product process development for biologics
Proficiency with Microsoft Office; familiarity with JMP, Prism, or Minitab a plus
Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment
Biotech/pharmaceutical industry experience strongly preferred
B.S. with 1-4 years of experience, M.S. with 0-1 years of experience, with degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Pharmaceutical Sciences, or related Life Sciences field with a pharmaceutical, vaccine, or biotechnology background

Process Development Technician Resume Examples & Samples

Operates all process equipment and laboratory apparatus for catalyst preparation and experimental studies in a safe and clean manner
Utilizes mixing and coating equipment to prepare prototype samples with support from supervisor or other technicians meeting all quality requirements and submits finished samples for all relevant testing
Effectively collaborates with other departments such as scientists, maintenance, analytical services, quality control, and engineering to overcome processing obstacles and complete prototype sample preparation within expected timings
Maintains clear and accurate records of catalyst preparation and experimental data using appropriate documentation
Begins to familiarize self with rationale for prototype requests through review of relevant documentation and interactions with technical staff
Performs standard calculations required to prepare 0.5 liter through 80-gallon sample batches
Completes monthly responsibilities such as inventory, 5S activities, and monthly report
Actively participates in continuous improvement projects seeking to improve processes and procedures to ensure best practices
Develops effective work relationships within PcD and with other groups, and works to build a network of resources to aid in troubleshooting
Develops the ability to problem solve and adapt procedures, techniques, tools, and equipment with guidance from engineers and lead technicians in order to complete required sample preparation
Must have one of the following
Comfortable using and working around power tools and equipment
Capable of routinely lifting up to 35lbs from floor to bench height and occasionally manipulating 50lb loads at or below waist level
Capable of standing or sitting for extended periods and able to crouch, kneel or otherwise reposition oneself while inspecting and maintaining product or equipment
Capable of being fitted with a full-face respirator

Process Development Associate / Engineer Resume Examples & Samples

Benchtop bioreactor operation and maintenance
Experience with mammalian cell culture
Experience with statistical design and analysis software (i.e. JMP)
0-2 years BS for Process Development Associate Level

Process Development Technician Resume Examples & Samples

Designing, developing and introducing processes for the assembly and testing of new products
Assembly of prototype and low volume product samples
Commission and trouble-shoot problems on process equipment
Write equipment validation plans and associated reports
Detailed product testing to confirm process performance
Sourcing parts required for process equipment
Identifying suitable process measures to assess process equipment efficiency
Identifying suitable maintenance plans and spares lists for process equipment
Conducting experiments with a structured and methodical approach
Demonstrate an ability to problem solve
Familiar with Renishaw production documentation
A basic appreciation of chemistry would be a benefit
Experience of working with high powered lasers would be a benefit

Process Development Associate Resume Examples & Samples

Activities include basic lab skills suitable for downstream work: pipetting, solution preparation, aseptic techniques
The incumbent will use basic lab skills for processing downstream work, including pipetting, solution preparation and aseptic techniques
Setup and operation of AKTA purifier and buffer exchange using UF/DF systems (familiarity with HPLC is helpful)
Perform assays, standard absorbance reading, ELISA, cell-based assays, running SDS PAGE gels, silver staining and developing gels, recording and reporting data
Maintaining accurate records of executed protocols/procedures and assay data - reporting results through the appropriate channels
Assisting with writing and revising technical documents including SOPs, testing protocols and reports
Maintaining stocks of lab supplies and reagents in accordance with internal lab practices and SAP
Supporting the process development and the technology transfer activities, proactively developing and improving new skills and knowledge necessary to successfully support assigned projects

Formulation & Process Development Technician Resume Examples & Samples

Assembles, disassembles, operates and cleans process equipment such as spray dryers, tablet presses, mills, roller compactors, fluid beds, and blenders
Performs routine physical characterization of products. (e.g. powder and tablet characterization)
Documents the formulation and process results in lab notebooks consistent with company policy and good laboratory practices
Tabulates, documents, and interprets processing data
Assists in troubleshooting of process-related issues
Maintains cleanliness of equipment, work areas and facility with assistance of assigned personnel
Performs general maintenance on research & development (R&D) process and laboratory equipment, as needed
Organizes and maintains process critical materials and equipment

Motors Process Development Technician Resume Examples & Samples

Use precision measurement equipment and accurately record critical build and test data. Participate in gauge R&R studies
Develop assembly and manufacturing processes working in collaboration with Engineers and other Technicians
Build test rigs including basic electrical wiring, compressed air and fire trace to pre-defined schematics
Adhere to safe working practices and lab rules
Proactivity seek to identify and implement as appropriate continuous improvement practices
Ability to interpret and interrogate engineering drawings and documentation
Experience of complex / skilled assembly or maintenance work
Practical and methodical approach to problem solving with a keen focus on attention to detail
Demonstrate the ability to work autonomously and as part of a team
Maintain a positive attitude with the willingness to approach any task, display drive and enthusiasm to succeed
Have a flexible attitude being adaptive to changing priorities
Display a basic competence of MS Word and Excel

Hamr Process Development Technician Resume Examples & Samples

Work as a process technician in the wafer Fab cleanroom
Candidate will work with development and manufacturing teams to process, inspect, perform metrology and disposition experimental wafers
Candidate will create recipes for vacuum tools - thin film deposition, ion beam etching, and/or reactive ion etching
Other responsibilities may include calibrating, monitoring and troubleshooting development tools
Job requires working either Saturday or Sunday
Minimum of five years experience in semiconductor and/or magnetic head wafer processing
Experience in one or more of the following areas - thin films, CMP, ion milling, reactive ion etching, metrology
Experience in working with R&D team on developing new processes and materials and running experiments
2 year college minimum in science or engineering. BS degree preferred but not required
Candidate must be detail-oriented and have strong oral and written communication skills and excellent people skills
Candidate must be able to work with minimal supervision and be highly self-directed

Process Development Associate Resume Examples & Samples

Produces notebook, pilot and production materials per written instructions
Supports execution of process validation of new and existing manufacturing processes under supervision
Assists with troubleshooting experimentation required for projects
Troubleshoots minor manufacturing process problems
Supports the development of manufacturing processes for transfer to Manufacturing
Keeps accurate records and documentation
Creates and submits simple standard operating procedure (SOP) changes
Typically Requires 8 GCSE's A-C grade (One in Biology and One in Chemistry) and related experience desired or 3 A levels (at least one science related) and related experience desired or BS Degree and related experience desired
Working knowledge of GMP/GLP
Proficiency with MS Word and Excel
Regularly required to sit
Regularly required to use a computer keyboard, mouse, and monitor
Regularly required to talk and hear
Occasionally required to walk to meeting locations
Required to use close vision and adjust focus
Work is performed primarily in an office environment
There will be a requirement to work within a laboratory environment

Process Development Associate Resume Examples & Samples

BS/MS in a biological sciences discipline, and 5+ years (BS) or 3+ years (MS) experience in Process Development, or equivalent combination of education and experience
Direct experience in a Process Development environment supporting aseptic cell culture based manufacturing operations. 2+ years hands-on experience with T-cell isolation and expansion protocols preferred
Experience in one or more of the following technical areas

Process Development Associate Resume Examples & Samples

PD level II will require: BS/MS in a biological sciences discipline, and 5+ years' (BS) or 3+ years' (MS) experience in Process Development, or equivalent combination of education and experience
PD level III will require: BS/MS in a biological sciences discipline, and 10+ years (BS) or 7+ years (MS) experience in Process Development, or equivalent combination of education and experience
Direct experience in a Process Development environment supporting aseptic cell culture based manufacturing operations including 2+ years hands-on experience with B-cell/T-cell/stem cell isolation and expansion protocols

Manager of Process Development Resume Examples & Samples

Manages the design and execution of process development (formulation, filtration, filling, lyophilization) and validation activities using Quality by Design (QbD) concepts where appropriate
Oversees process technology transfer activities from external facilities and between Development and production
Manages Process Development staff and provides technical support and guidance to help maintain project timelines while assuring compliance to all regulatory requirements
Reviews experimental design, development reports, experimental data, protocols and protocol reports
Provides miscellaneous technical support to Production, Engineering and Quality groups by leading process investigations and product impact assessments
Works with Production, Engineering and Quality groups to help with assessment and implementation of new process techniques and technologies
Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements for product submissions
Excellent communications and project management skills
Excellent technical writing ability
Ability to optimize the job satisfaction and performance of scientists on an individual and group level
Knowledge of regulatory compliance requirements related to process development/validation
Solid knowledge of chemical principles and their practical applications to process development
BS in related field, MS preferred
Minimum 5 years related management experience with excellent track record for meeting objectives and deadlines with prior experience in a pharmaceutical environmen
Responsibilities and Tasks
Knowledge Skills and Abilities
Minimum 5 years related management experience with excellent track record for meeting objectives and deadlines with prior experience in a pharmaceutical environment
Strong technical knowledge in process development including prior experience in formulation and lyophilization cycle development
Demonstrated ability to assess, manage and mentor individuals to maintain high levels of scientific competency and group performance

Head of Downstream Process Development Resume Examples & Samples

Oversight, scheduling, planning and reviewing of new Ad5, AAV, lentivirus and other vector process development and tech transfer experiments in the PD lab related to all downstream processes and in-process analytics, to include process optimization and problem-solving processes and equipment. Uses DOE when needed
Critically analyzes processes for improved recoveries, through-put and scalability, and utilizes background and expertise in downstream purification, and product formulation technologies to establish and optimize new processes for incorporation into viral product manufacturing
Accountable for analysis of data from downstream, generation of reports and tech transfer documentation (BFD, PPL, etc) as well as oversight on new development protocols, and IP disclosures when applicable. Technical writing to include SOPs, PD batch records etc
Drives downstream viral vector Process Characterization activities
Serves as viral vector SME for proposals, new client development and for downstream team to design and execute study plan; represents Lonza C&GT in technical presentations and reports and industry conferences
Accountable for meeting timelines and achieving timely deliverables, and shaping communication of results to clients and internal cross-functional teams
Closely interacts internally with other departments principally Manufacturing Sciences and Technology, GMP operations, and Program Management for as an SME for downstream PD functions, and externally with vendors to identify and secure new technology
Must have thorough knowledge of cGMP requirements and facilities to put safety and product quality first
Must have formal, demonstrable understanding of tech transfer and scale-up using chromatography skids, UF/DF, of formulation development through pilot-scale facilities. Solid understanding of and experience with in-process and final product analytics for product quality monitoring is a must
Demonstrated leadership and prioritization abilities; ability to motivate, deliver and to excel in a team setting are essential for this leadership position
Prior experience with PD automation such as TECAN is desirable, as is prior experience on the manufacturing floor
Prior experience in late-stage clinical or commercial product development of virus or protein is highly desirable

Associate Director, Process Development Resume Examples & Samples

Leads a team of scientists and research associates to optimize monoclonal antibody production in large scale culture
Provides technical and scientific guidance to team members
Collaborates with and supports Manufacturing, Product Discovery, and other groups within the organization to meet organizational objectives
Develops, scales up, and troubleshoots cell culture and primary recovery of monoclonal antibody products
Designs experiments, analyzes data, and draws conclusions
Ensures accurate and complete documentation of lab activities to ensure appropriate regulatory submission
Writes technical reports for tech transfer and regulatory submission
Evaluates productivity of cell lines, feed strategies, and process control parameters in bench-top bioreactors (1L) to pilot scale bioreactor (60L)
Ensures the production of material for preclinical and toxicology studies
Develops media and feed formulations, optimizes bioreactor conditions, and demonstrates scalability of the processes
Develops and implements new technologies to streamline cell culture process development and manufacturing
Works with vendors to evaluate new technologies
Implements QbD (quality by design) approaches and utilize DoE (design of experiment) and metabolic modeling to optimize processes
Leads activities in bioreactor design, characterization, process monitoring and development of control strategies
Manages tech transfer to clinical production at 2500L bioreactor, lead scale-up and troubleshooting activities
Maintains substantial current knowledge of new technologies and innovations in the field of MAb cell culture and production
Works with senior leadership team to maintain an environment that fosters teamwork, collaboration, and innovation
Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance
Works on problems of diverse scope where analysis of situation or data requires a review of complex data
Performs additional job related duties as required
Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 5 years of relevant experience
Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts
Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization
Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
Possesses strong attention to detail, the ability to maintain accurate records and excellent proofreading skills
Excellent problem solving skills as well as time management and organizational skills
Proven ability to manage others, assign and schedule work, and conduct performance evaluations
Able to travel as needed
Previous experience in a cGMP environment
Experience with Design of Experiment (DOE) software

Process Development Associate Resume Examples & Samples

Mathematical modeling, experimental design and data analysis supporting biologic process development
Analysis of data by statistical or DoE software, and graphical procedures in order to provide accurate, concise and pertinent summaries and data reports
Assists with the scale-up & technical transfer of cell culture and purification processes to GMP Manufacturing
Assists with troubleshooting, root cause analysis and identification of corrective actions to support Pharmaceutical Development or GMP Manufacturing equipment and process issues
Operation and maintenance of laboratory and pilot-scale cell culture and biologic purification systems
Perform analytical biochemistry and molecular biology assays as well as microscopy and other laboratory testing as required
Keep accurate records in notebooks, organize and report results
Prepare written and oral reports for presentation to the development group and senior staff
Maintain reagent inventories, order supplies, cleaning of laboratory areas, hoods, incubators and group equipment
Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies
Perform additional job related duties as required
Requires a Bachelors degree in Chemical Engineering, Chemistry, Biochemistry or related field with a minimum of 0 to 2 years relevant work experience
Prior experience with biologic purification or cell culture and aseptic techniques preferred
Familiarity with Microsoft Office & JMP or similar statistical software
Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors
Normally receives general instructions on routine work, detailed instructions on new assignments
Demonstrated ability to work both independently and as a member of a team

R&D Group Leader Gum & Candy Process Development Resume Examples & Samples

Master Degree in Chemical engineering, Food Technology or Food Engineering
More than 7 years’ experience of practical application in Product/Process Development within Food industry. Experience in confectionery is a strong advantage
Proven records of multiple industrialisation experience in FMCG
Good knowledge on food manufacturing technologies, ingredients and ability to operate the equipment
Experience with RD&Q systems such as Specification Management System, Project Management System, Quality Management, Productivity Tracking
Solid experience in people management, more than 5 years
Ability to work across boundaries / functions and to collaborate with others to deliver results
You are able to manage complexity and exhibit out-of-the-box thinking and an innovative mind-set
Ability to apply technical know-how to understand and develop product and processes
Strong knowledge in Food safety and Lean Six Sigma
Flexibility and stress resistance whilst managing work load within a tight time frame
Fluency in English required, other language skills (Polish) are beneficial

100

Head of Upstream Process Development Resume Examples & Samples

Oversight, scheduling and planning of new AAV, Ad5, Lentivirus and other process development and tech transfer activities in the PD lab related to all upstream processes, to include process optimization and problem-solving processes and equipment
Critically analyzes processes for improved productivity, through-put and scalability, and utilizes background and expertise in upstream viral production, harvest and recovery technologies to establish and optimize new processes for incorporation into viral product manufacturing
Accountable for upstream data analysis, generation of reports and tech transfer documentation (BFD, PPL, etc) as well as oversight on new development protocols, and IP disclosures when applicable. Technical writing to include SOPs, PD batch records etc
Drives upstream viral Process Characterization including C&E and Risk analyses, FMEA, and DOE to provide process characterization package
Serves as viral vector development and production SME for proposals, new client development and for upstream team to design and execute study plan. Represents Lonza process development in publications and presentations at conferences
Accountable for meeting timelines and achieving timely deliverables, and clearly communicating results to clients and internal cross-functional teams
Closely interacts internally with other departments principally Manufacturing Sciences and Technology, GMP operations, and Program Management for PD functions, and externally with vendors to identify and secure new technology
Outstanding technical writing and oral communications skills are mandatory
Demonstrated experience with viral vector production process scale-up (AAV preferred) with a solid understanding of STR, clarification/depth filtration, UF/DF including hands-on expertise with scalable bio-production platforms and equipment
Demonstrated skills in problem-solving and proposing solutions
Demonstrated ability to prioritize projects and manage time of self and reports, including the ability to meet immutable deadlines
Independent work skills; strong work ethic; delegating skills; ability to motivate and to excel in a team setting are essential for this leadership position

101

Process Development Technician Resume Examples & Samples

Supporting the introduction of processes for the manufacture, assembly and testing of new products
Perform validation and prototype work to implement and verify designs during the process development phase
Assisting with the build, wiring, piping, testing and implementation of bespoke assembly equipment
Support of process equipment to ensure they are maintained, calibrated and downtimes are minimised
Fault finding and repair of equipment with proposals and implementation of corrective actions
Basic design tasks associated with the introduction of new processes
Exposure to technician level support of production processes
An understanding of structured problem solving (e,g, Six Sigma Yellow Belt)
An understanding of control systems and their implementation
Experience of assembly automation
Training and experience in the use of manual lathes and milling machines

102

Director, Process Development Resume Examples & Samples

Study the scaling up process of lab formula for smooth transition to real manufacturing/production scale communicating well with formulation and technical department. Active participation in the resolution of manufacturing issues. Responsible for compliance of assigned work area with company set standards for laboratory safety and general maintenance
Work with formulators from the early development stage of project, and foresee the potential quality and process issues. Advise formulators to avoid predicted problems in regard to not only process but formulation point of view
Understand, follow, and adhere to project cost objectives and timelines developed for each project. Follow requirements of the new product development process and follow through with action plans to meet the goals and timeline of the project. Track project timelines from Clarity system to insure targets are achieved
Participate manufacturing trial runs of products, works with Formulators and Technical team. Attend Technical pre-trial run and post-trial run meetings
Interact with manufacturing machine vendors and other industry representatives to further expand on the understanding of their products, technologies, and services. Utilize professional relationships to further expand and bring appropriate technologies in house. Search and assess new interesting instruments for manufacturing and evaluating the products
Develop new process technologies to create innovative products. Seek out external institutes and read industry literature as it relates to new assignments and technologies
Manage the process development group creating the strong team. Educate and motivate junior process development members
Bachelor’s degree in chemistry, chemical engineering, or equivalent science
Minimum 15 years in process development experience
Knowledge of industry trends
Motivated and works well in teams and independently
Requires strong organization, communication and writing skills

103

Process Development Manager Resume Examples & Samples

You interact with production, sales and international customers on possible process changes, qualification schemes and future needs
You manage R&D programs and projects supporting such process changes in all aspects, being detailed definition, budgeting, implementation, follow-up and reporting
You ensure the process changes are challenged, well documented and translated in clear work instructions for production
You build up specific expertise and research techniques and share this with your colleagues

104

Manager CHC Formulation & Process Development Resume Examples & Samples

Lead product/process development and commercialization activities (as either an individual contributor or technical leader of junior level scientists) for new immediate release and modified release solid oral dosage forms interfacing with Analytical Research & Development scientists to facilitate “First-to-File” and “First-to-Market” corporate goals
Lead the manufacture of Pivotal/Registration lots for new products in the Formulation/Process Development Pilot Plant and Manufacturing facilities
May supervise and mentor team of junior level scientists and technicians in the design and execution of product development activities
Design and perform quality scientific experimentation to develop robust processes in support of Product Development activities
Contribute to the development of new experimental approaches using Quality by Design approaches. Design and conduct stability studies. Analyze and defend scientific results from experiments
Generate accurate, reliable data by following established procedures and practices to support product development. Record, tabulate, summarize, interpret, report and publish results
Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale up and process confirmation batches
Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and Regulatory Affairs
Interacts with regulatory agencies, as needed basis
Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope Formulation/process development and improvement projects
Communicates effectively to project manager and the wider development team and presents data at team meetings and departmental technical meetings
Leads and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits
Ensure compliance with current Good Manufacturing Practices (CGMP), Perrigo policies and Quality Systems, and all applicable regulatory agencies
Considerable breadth and depth of problem solving experience is necessary
Excellent communication skills and the ability to represent the department to both internal and external constituencies are required

105

Process Development Co-ordinator Resume Examples & Samples

Co-ordinating continual development of in-house processes
Co-ordinating and prioritising system change activity across the group’s facilities
Co-ordinating change management of all aspects of operations systems and processes, in a dynamic and complex environment
Liaise with IT Development team with related operational projects and issues
Support Project Management and implementation of machinery and integration with IT systems
Work closely with the Engineering team when implementing changes
Encouraging employee participation in continual improvement, raising quality, efficiency and effective team working
Promoting a flexible approach to delivering business requirements
Providing accurate timely management reports and information
Use Microsoft Projects to compose Gantt charts etc
IT Literacy
Excellent interpersonal and communication skills at all levels, including direct reporting to senior management
Strong project skills
Previous experience in warehousing, logistics or warehouse automation related projects
Ability to resolve problems independently providing solutions and resolution

106

Process Development Technician Resume Examples & Samples

Development and scale-up of manufacturing technologies for Plene processing
Bring engineering expertise to new product development and applies best practice in scale-up and process development to ensure quality and capacity targets
Applies specialist knowledge of manufacturing technology to deliver increases in capacity and product quality through the debottlenecking and optimization of Plene processing assets
Identifies, implements and promotes best practice in production technology at Syngenta Plene site
Evaluates and perform trials in manufacturing equipment, processing techniques and works with site manufacturing team to introduce into full-scale manufacture in Plene operations
Mechanical or Chemical Technician (mandatory)
Graduation students of the last year of Mechanical Engineering or Production Engineering careers with availability to intern for 2 years (preferably)
Basic to intermediary knowledge of SAP essential (purchase orders, invoices, etc.)
Advanced Office Package user (Mandatory)
Intermediate level of knowledge in statistical validation (desirable)
Preferably with basic knowledge of Jump software
Skilled with industrial processes and systems
Intermediate level of English language

107

Engineer, / II, Process Development Resume Examples & Samples

Provides technical support to process development and commercialization activities (in collaboration with senior level engineers) for new immediate release and modified release solid oral dosage forms interfacing with Product Development scientists to facilitate “First-to-File” and “First-to-Market” corporate goals. Supports the manufacture of Pivotal/Registration lots for new products in the Product Development Pilot Plant
Provides support (to senior level engineers) in the design and execution of quality scientific experimentation to develop robust solid oral dosage processes in support of Product Development activities. Generates accurate, reliable data by following established procedures and practices to support process development. Designs and interprets experiments with input from senior level engineers and product development scientists. Records, tabulates, summarizes, interprets, reports and publishes results. Hands on process development experimental design, development and optimization with guidance as appropriate. Analyzes and Defends scientific results from experiments
Provides support (to senior level engineers) in the preparation of Process Development documents for inclusion into the eCTD and Quality Overall Summary (QOS) when required
Prepare documents for registration batches, submission and commercialization activities (with minimal guidance)
Review and ensure the reliability of technical data related to process and related analysis
Provide support to troubleshoot equipment and training to Product Development staff
Support compliance with current Drug Enforcement Administration (DEA), Good Manufacturing Practices (cGMP), IMPAX policies and Quality Systems, and all applicable regulatory agencies
2 or more years of related experience and/or training in Pharmaceutics, Chemical Engineering, Chemistry or equivalent scientific/engineering discipline (with a Master’s degree) required
OR, 3 or more years of related experience and/or training (with a Bachelor’s degree) required
Knowledge and experience in Pharmaceutical processes/optimization, equipment, validation and technology transfer required
Knowledge of current FDA technical initiatives (that include, but are not limited to, QbD, PAT), SUPAC (Scale Up and Post Approval Changes), cGMPs, compliance and validation guidance is mandatory required
Knowledge in immediate and modified release oral dosage formulations and technologies required
Knowledge of scale-up and technology transfer to commercial manufacturing required
High level of computer literacy required

108

Process Development Manager Resume Examples & Samples

Review and optimize the current process to deliver a finished, commercially-viable, food-grade food/dietary ingredient (cocoa extract) within agreed quality specifications while ensuring the operational costs are minimized
Understand the costs of manufacture, including those related to different process alternatives, and determine the most cost efficient method
Evaluate alternative extraction technologies, including as needed alternate manufacturing operations, and present options to management on advantages/disadvantages of each
Support engineering activities in Indonesia and as needed, alternate origin countries that support cocoa extract manufacture
Develop and maintain specifications for materials and ingredients relevant to the manufacture of the finished ingredient (cocoa extract)
Responsible for knowledge management (generate, manage, analyze, and maintain critical data) related to processes and finished ingredient, including shelf-life studies
Work cross-functionally with Product Development, Quality & Food Safety, Analytical, and Material Science teams in the manufacture, development, and use of cocoa extract
Work cross-segment on activities related to cocoa supply chain and manufacturing
Understand existing IP and work to develop new IP to protect Mars Symbioscience as a leader in the supply of flavanols
Manage manufacturing and R&D trials at third party facilities with little or no direct supervision
Role requires travel -domestic and international, up to 30%
Demonstrated ability to build to lead projects
Ability to chart the future in an ambiguous environment
Ability to identify risks and benefits, and make appropriate business recommendations
Highly adaptable to change
Background in US regulatory environment related to the production of human foods and/or dietary ingredients
Experience in a human nutrition/health-focused business/business applications

109

Process Development Co-ordinator Resume Examples & Samples

Design and support the manufacture of catalysts in order to comply with customer and legislative requirements, giving due consideration at all times to Quality standards, EHS and Sustainability
Produce and interpret complex technical data, for circulation and presentation to internal and external customers, to assist with the improvement of products and processes to gain competitive advantage
You will Coordinate appropriate resources, including direct reports and will be a key point of contact for other Technology Centre and Production departments
This role will involve some travel to other JM Plants across the region
16 July 2017

110

Engineer, Advanced Process Development Resume Examples & Samples

Support the development and implementation of early stage processes and technologies concurrently with the R&D New Product Development and Manufacturing Engineering
Scale up new and capable manufacturing processes from R&D to Commercial Production
Upgrade and design fixtures and automated production and test systems for cleanroom manufacturing environment
Utilize structured methodologies such as six sigma to identify potential improvement projects, technologies, design houses and concepts based on design, manufacturing and business requirements
Evaluate manufacturing processes that could be automated for value-add and develop a strategy for application of new technology
A Bachelor's degree in an engineering or science discipline is required. An Electrical or Mechanical Engineering Degree is preferred
A minimum of 2 years of experience in designing and implementing automated equipment as well as hands on application of automation, within an FDA regulated manufacturing environment, is required
Experience scaling up processes from R&D to commercial production or expansion
Knowledge of standards related to equipment design and implementation into global medical device manufacturing plants
Writing skills to develop requirements specifications and proven ability to write Requests for Proposal and Quote
Demonstrated knowledge of financial budgeting and financial acumen to evaluate the value of various new technologies and make financial and technical based recommendations to the business
Must have a demonstrated track record of effectively influencing others, internally and externally

111

Process Development / Cntrl Sp Resume Examples & Samples

Administer comprehensive efficiencies studies to ensure maximized utilization of all resources; identify process flaws that result in poor service and/or products
Implement and monitor process improvement initiatives and metrics systems
Work with branches to ensure process efficiencies are implemented and maintained
Provide detailed analysis reports, including financial and cost savings summaries
Develop process related training programs & materials for both USGS and branch staff, and conduct on-going training/development initiatives
Experience in the freight or security transportation business
Experience performing process analytics
Strong consultative, analytical and problem solving skills
Excellent interpersonal, communication and presentation Skills

112

Undergrad Coop Process Development Resume Examples & Samples

Use mathematics expertise for process data gathering and analysis
Perform advanced statistical analysis to support multivariate analysis and/or process monitoring platforms (Digital Development Program)
Make effective business/scientific presentation
Work with multidisciplinary teams and teams to handle multiple projects at one time
Work on software such as MiniTab, JMP and Excel
Organize & analyze data and present results
Interpretation of results for operational issues and or experiments/studies related to projects
Interact constructively with peers
Pursuing a Bachelor’s degree in Statistics and/or Mathematics
At Least 3.00 GPA (General)
Have completed at least 3 years of college education
Be enrolled in School
Not yet graduated
Be pursuing an applicable degree or course of study
Basic Technical report writing and presentation skills
Analytical Problem Solving and organizational skills
Team work oriented

113

Process Development Technologist Resume Examples & Samples

Minimum Batchelor level University Degree /professional technical qualification in Science or Engineering or equivalent
Recognised brewing qualification, preferably Master Brewer IBD
Brewing experience preferred with a minimum of 1 year of experience in Brewhouse, fermentation or maturation/filtration
International brewing experience and advantage (operations or technical)
Excellent communication skills – verbal & written
Proven experience in delivering technical projects

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