Analytical Development Resume Samples

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L Krajcik

Lelah

Krajcik

54447 Arch Underpass

Los Angeles

+1 (555) 621 2013

54447 Arch Underpass

Los Angeles

Phone

p +1 (555) 621 2013

Experience Experience

New York, NY

Mgr, Analytical Development

New York, NY

Abshire LLC

New York, NY

Mgr, Analytical Development

Help institute new work processes and initiatives to improve efficiency, work flow and turn around time
Represent the Analytical Development group by participating in departmental and company project teams
This position will report to the head of the Analytical Development group, and will fill in as the acting head of the Analytical Development group in the absence of the head
Ensure that the work performed by direct reports meet pharmaceutical industry and internal company standards for quality and timeliness. Primary duties of direct reports will include the following
Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites
- Develop and validate methods to test pharmaceutical raw materials and finished products for strength, identity, impurities and dissolution performance by commonly used techniques
- Test and release raw materials and finished products in support of internal product development

Dallas, TX

Director, Analytical Development

Dallas, TX

Abbott, Williamson and Kuphal

Dallas, TX

Director, Analytical Development

Contributes towards developing and governing harmonized business processes and tools related to development, tech transfer and commercial product management
Team provides process support to internal and external manufacturing sites, manages the resources, leads technical initiatives, and process knowledge management
Provide technical leadership in various governance committees and functional, cross-functional and program-related decision making bodies
Champions high throughput analytical testing approaches via the use of automation and robotics
Sets high standards for talent acquisition and development for the department. Key participant in the hiring, development, and performance management of analytical staff
Encourages new ideas and processes, and encourages new approaches
Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication

present

Detroit, MI

Director, Analytical Development Stability

Detroit, MI

Ondricka, Wehner and Sauer

present

Detroit, MI

Director, Analytical Development Stability

present

Assisting in the response to FDA queries regarding new products
Direct management and of the Laboratory staff
Responsibility for the development of CMC sections for assigned new products for FDA submission
Analytical method development and validation of new products
Supervision, training, and development of the Director’s team
In-depth knowledge and training in project management and analytical study activities
Responsibility for GMP compliance of laboratory operations

Education Education

Bachelor’s Degree in Biology

Boston University

Bachelor’s Degree in Biology

Skills Skills

Strong sense of value of investment and ability to develop cost-effective development plans
Solid understanding of how Biopharmaceutical Development integrates with key business partners
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment
Proven leadership ability to align, motivate and empower team members
Demonstrated ability for critical thinking, problem solving and innovation
The ideal candidate will also have experience in interacting with CROs
Demonstrated track record in product characterization utilizing mass spectrometry and related technologies
Effective communication, collaboration and negotiation
15 years pharmaceutical bio-analytical experience with exposure to all stages of biologics development

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15 Analytical Development resume templates

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Analytical Development Specialist Resume Examples & Samples

Analytical method execution, qualification and development of separation and plate based methods
Documentation of data and results as per SOP and compliance documents
Contribute to method development including MS based methods
Sample handling including sample log in, labelling and storage as per guidelines
Conduct methods for peptide map, glycan map, SEC, RP-HPLC and IEF
Conduct methods for receptor binding and other plate based
Communicate with development SME and lead as well as assist in method remediation/trouble shooting
Participate in method qualification as an analyst
Document all data and results as required
Communicate with PD colleagues and stakeholders about testing results and resolve any issues with testing/results of assigned samples
Perform assigned duties to maintain and improve practices within the testing group
M.S. with three years of directly relevant biopharm industry experience
B.S. with five years of directly relevant biopharm industry experience

Director, Analytical Development Resume Examples & Samples

The Director will be responsible for guiding the commercialization of analytical methods that are “fit for purpose” and meet current agency expectations. In addition he/she will be required to apply physicochemical and biological characterization strategies to aid structure/function studies in support of QbD, comparability studies, etc
The Director should be prepared to develop the department’s technical and product development capability. Knowledge and experience in cGMP analytical work is required
Accountable for driving resolution of biologics manufacturing process challenges, for ensuring knowledge management and sharing of best practices for biologics DS/DP tech transfers and commercial process lifecycle management. Reviews and approves protocols and technical reports, ensures adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data to support changes/improvements
Contributes towards developing and governing harmonized business processes and tools related to development, tech transfer and commercial product management
Knowledge and expertise in working with CRO/CMO on method development and qualification is a must. He/she should be able to demonstrate a successful track record of working with external contract organization in delivering analytics for regulatory filings
Reviews and approves protocols and technical reports, ensures adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data to support changes/improvements
Team provides process support to internal and external manufacturing sites, manages the resources, leads technical initiatives, and process knowledge management
Prioritizes work and deploys resources to ensure that all projects are successfully executed. Key accountability is to provide technical leadership and technical capabilities to Process Development
Provide technical leadership in various governance committees and functional, cross-functional and program-related decision making bodies
Working knowledge of GMP compliance as related to analytical laboratory
Technical expertise in analytical chemistry

Head of Large Molecule Analytical Development Resume Examples & Samples

As a China Pharmaceutical Development and Manufacturing Sciences (PDMS) leadership team member, the Associate Director/Director (depending on experience) will take the primary responsibility to lead the China Large Molecule Analytical Development team and to grow the AD team end-to-end biopharmaceutical product development and commercialization capability over time
The Associate Director/Director is responsible for co-developing analytical development strategies with the global PDMS in supporting local China R&D projects sited in China, in line with the customer’s expectations, and translating the development strategies into plans in alignment with internal stakeholders and external partners
The Associate Director/Director is responsible for Implementing and executing of the developed strategies by providing scientific leadership and technical oversight, managing day-to day activities to ensure adherence to timelines and budgets, and improving existing or developing new technologies based on customers’ needs
The Associate Director/Director is also responsible for building, strengthening and maintaining an external network of CROs based on a balance of cost, time, quality and value
The Associate Director/Director will be the primary contact for large molecule analytical development related activities in China while acting for the global PDMS organization and for the China R&D organization
Comprehensive knowledge and hands on experience with large molecule also known as biologics analytical development for the molecules ranging from clinical development to commercial production stages. Specific experiences included but not limited to method development, validation, and transfer for in-process control, release, and stability testing. Analytic technologies include but not limited to HPLC/UPLC, CE, cell-based bioassay, qPCR, mass spectrometry, and immunoassays. A strong knowledge in structure/functional assay is a plus
Extensive knowledge in product characterization and comparability evaluation using mass spectrometry and biophysical methods such as CD, DSC and AUC. Extensive knowledge and experience in PTM determination and characterization, structure/function, and MOA are highly desired
Support of drug substance and drug product manufacturing processes development and productions
Establishing and overseeing external partnerships with development and supply parties
Demonstrated ability to lead an analytic team, foster team productivity and cohesiveness, work collaboratively to execute, deliver and get results in a matrix environment
Large molecule CMC experience is required. Experience in analytical development IND/BLA authoring are highly desired. Preparation of regulatory submission for filing in China and being able to respond to global and local health authority are preferred
Relevant experience in China and preferably, also abroad at an array of development and/or manufacturing sites in leading teams and/or projects. Familiarity with China regulatory is preferred
Strong analytical problem solving skills are required
It is required that the candidate be highly organized and capable of managing/pursuing multiple projects
Good written and verbal communication skills are required in addition to excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamicsProduct Development

Contractor, Analytical Development Resume Examples & Samples

Experience in protein analytical methods including SDS-PAGE, liquid chromatography, mass spectrometry and ELISA, etc
Mammalian cell culture experience is a plus
The ideal candidate should have a B.S. or M.S. degree in biochemistry or related disciplines with 1-5 years of experience

Director, Analytical Development Resume Examples & Samples

Science: The Director is responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Development with delivery of physico-chemical characterizations and analytical methods, timely data, and process knowledge needed to meet Celgene project milestones and associated regulatory and international requirements. This includes the design of protocols, execution, reporting and approval of characterization, validation and qualification reports that support development activities
Quality and Regulatory Standards: Develops and implements quality standards and specifications for drug substance and drug products under development and reviews and ensures the delivery of high quality-related sections in CMC sections of IND/CTA/NDA filings for Celgene NCEs. Addresses quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications
Compliance Systems: Sets a high compliance standard and ensures that systems and resources are in place to ensure the activities of the laboratories are conducted in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, DEA regulations and OSHA safety standards and in accordance with corporate requirements. Ensures overall laboratory readiness for regulatory inspections (FDA and DEA) and internal audits
Manages Projects and teamwork: Responsible for quality, quantity and timelines for analytical projects and bringing analytical representation and expertise to CMC and project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Ensures the department works as a development partner with collaborators and teams and facilitates the interpretation of data and the development of process knowledge to contribute to team and company goals
Human Resources: Responsible for setting high standards, building and managing a high performing group. Diagnoses and defines strategies for effective performance. Sets department goals and performance objectives, supports personnel development and addresses performance issues. Identifies department needs and recruits/hires/promotes personnel as appropriate. Develops internal talent through coaching, training and other relevant experiences that meet the needs of the organization. Allocates proper resources for meeting goals and objectives. Shares responsibility for the department budget, including external contract testing expenses, capital and personnel requirements. Develops quality performance metrics to guide resource allocation, productivity of operations and continuous improvement
Communications: Maintains productive communications with staff, Pharmaceutical Development colleagues, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper prioritization and the timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs. Establishes effective partnerships/relationships through collaboration, expertise in current and future analytical technologies, and seamless transfer of information. Understands needs and considers external customers and/or internal clients in decisions and actions. Encourages and supports collaboration across departments and takes actions that are best for Celgene
Creates an impactful vision for the analytical function and communicates a supporting strategy to align people, resources and management within their department, cross-functionally, and at CROs or other partner organizations as needed
Delivers results with the proper blend of scientific rigor, development phase-appropriateness, and business acumen. Strives for continuous improvement
Sets high performance expectations and holds others accountable for the results expected
Sets high standards for talent acquisition and development for the department. Key participant in the hiring, development, and performance management of analytical staff
Encourages new ideas and processes, and encourages new approaches
Serves as a delegate for selected review/approval and management responsibilities for the Executive Director, as needed
Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
Influences and impacts others through building and maintaining strong networks that are leveraged to obtain critical information and accomplish objectives
Anticipates needs, assesses and manages risks and organizational dynamics as well as their implications
Expert at strategic planning, including the building of various options to meet AD project goals that achieve different balances of speed, cost, and risk. Able to envision, articulate, and deliver on a scenario that achieves the balance required by the project team
Recognizes and resolves broad based complex issues across organizational boundaries
LI-KM1

Senior Director, Analytical Development Resume Examples & Samples

Provides strategic leadership, technical expertise, and specialized knowledge in analytical method development for release and stability testing of drug substance, raw materials, intermediates and drug product
Identifies analytical science capabilities and technology tools needed to enable manufacturing process development, QC testing, and new drug candidate formulation development
Applies scientifically-driven thinking to the development of scientifically sound, well understood, and robust analytical methods
Coordinates with other internal departments to review/approve qualification/validation of analytical methods
Leads analytical method transfer, qualification and validation to commercial QC and as needed for contract laboratories
Review of raw data packages associated with release testing, stability testing, and other characterization testing of drug substances and drug products
Leads development of scientifically sound and data driven specifications and represents Analytical Development at the Specifications Committee
Oversees analytical and QC activities at CMOs and Contracting Testing Laboratories (CTOs), including the review and approval of test records, forms, methods, protocols and reports
Prepares and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions
Set up and perform experiments in the laboratory in support of pre-formulation, analytical method development, manufacturing process development, and troubleshooting
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
Provides support and contributes to other analytical and Quality Control activities as necessary
Degree in chemistry or other scientific discipline (graduate degree is preferred)
10 years or more in the pharmaceutical industry with a minimum of 8 years in analytical and QC area
Experience in analytical method development/validation is required
Experience with drug/device combination products is a plus
Experience with analytical method development for proteins and peptide is preferred
Hands-on experience with analytical method development and validation
Experience with managing internal and external analytical and QC labs
Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing 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

Co-op, Analytical Development Resume Examples & Samples

Learn to operate a variety of mass spectrometers and HPLC equipment, optimize conditions and chromatographic separations for compounds of interest, and develop methods based on findings
Search, summarize and present literature topics of interest to project
Prepare poster/written presentations summarizing work
Must be enrolled in a College/University and have at least finished two years of a Bachelor’s Degree in fields of study such as Chemistry, Physics, Biology
Candidate must be enrolled in an advanced degree program if graduating in 2016
Legally eligible to work onsite
Some undergraduate research experience
Be highly-motivated and have an excellent work ethic
Experience operating laboratory instrumentation, beyond that gained in course work, especially HPLC and mass spectrometry
A desire to be part of a highly innovate company aimed at transforming lives of people with serious diseases, their family and society

Manager, Molecular & Analytical Development Resume Examples & Samples

Provide managerial oversight for the following
Processing activities of incoming samples, reagents etc. to support GMP/GLP studies including clinical release, stability, validation and method development activities
Shipment of outgoing samples and other materials for validation work, development projects, and outsourced testing
Issuance of sample documentation and the facilitation of qualification reports, validation reports, method reports, technical reports, and Certificates of Analysis
Coordinate with Analytical Team Leads (ATLs), Internal and external partners and ensure accurate documentation, inventory control, timely distribution, tracking and approval of samples and data for internal and external labs
Oversee off-site storage program ensuring robust tracking and inventory is maintained
Ensure maintenance, calibration and equipment logs for sample management are up to date and GMP/GLP inspection ready at all times
Serve as system administrator for refrigerator/freezer temperature monitoring system. Provide support for internal and external use of Lab Information Management Systems (LIMS)
Provide managerial oversight for continuous GMP/GLP and efficiency improvement initiatives
Support QA with audits, investigations or CAPAs related to sample management and author/update SOPs as it relates to department
Bachelors or Master’s Degree, preferably in the biological sciences, with a minimum of 10 years of relevant experience in biologics development the pharmaceutical industry or equivalent, in a GMP environment
Or a Ph. D. , preferably in the biological sciences, with 4 or more years of relevant experience in biologics development, the pharmaceutical industry or equivalent, in a GMP environment
Additionally, 2-5 years of demonstrated experience in an administrator role for computerized systems is a plus
Experience with Lab Information Management Systems (LIMS) e.g., Labware LIMS, Sample Manager LIMS is a plus
Possess excellent working knowledge of cGMP, GDP, GLP
Demonstrated problem solving ability, attention to detail, and analytical thinking skills
Skill in communicating/escalating critical issues to appropriate management is necessary
Strong written and oral communication skills is essential and a background in project management skills is a plus
Experience with Process improvement methodologies (Six Sigma, Lean Sigma) is a plus
1603905

Director, Analytical Development, Biologics Resume Examples & Samples

Create, define, and lead an attribute sciences team within the analytical development organization to meet the expanding needs of the Celgene Biotherapeutics pipeline
Build the scientific knowledge, capabilities, and strategies in molecular characterization that enable fast to clinic/fast to market product development and commercialization. Maintain current awareness in areas of expertise
Lead the overall scientific, technical and operational efforts within Analytical Development in regards to physicochemical characterizations and analytical methods
Establish procedures and protocols that would enable a deeper understanding of the impact of molecular attribute on product safety and efficacy to justify and establish the control strategy
Deliver timely data and process knowledge needed to meet Celgene project milestones and associated regulatory requirements. This includes the design of protocols, execution, reporting and approval of characterization and qualification reports that support development activities
Establish internal capabilities and tools for rapid characterization of product quality to enable upstream, downstream, and formulation development and optimization
Identify and establish partnerships with external vendors to leverage capabilities not available in-house
Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support discovery and product development
Maintain currency with applicable global regulations and industry standards for analytical testing and characterization of biological products
Define science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture
Develop the bio-analytical staff to function effectively in cross-functional teams and collaborations
Maintain a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs. Budget and track external expenses for CMO/CRO bio-analytical activities
Interact effectively and transparently with functional leads within Biologics Development, and with other Celgene stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Business Development, Alliance Management, etc.)
Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Biologics Development
15 years pharmaceutical bio-analytical experience with exposure to all stages of biologics development
Demonstrated track record in product characterization utilizing mass spectrometry and related technologies
Direct experience in CMC analytical and regulatory requirements, including development of product specifications and extended analyticalcharacterization, to support early and late stage product development and global commercial registration submissions
Solid understanding of how Biopharmaceutical Development integrates with key business partners
Effective communication, collaboration and negotiation

Gstc-analytical Development & Commercialization Intern Resume Examples & Samples

Available for a minimum of 10 week internship beginning June 2017
Excellent academic record and achievements
Research-oriented with excellent problem-solving skills
Good team player, self-motivated, takes initiative, and independent
U.S. citizen or lawful permanent resident of U.S
Solid academic background in Analytical, Organic, and/ or Physical Chemistry
Basic lab experience performing chemical experiments and applying common lab techniques and instrumentation such as chromatography and spectroscopy
Basic experience with statistical analysis and data presentation software and tools, including Microsoft® EXCEL
Strong personal character and ethics
Relevant work experience is preferred which may include any of the following
Experience utilizing analytical tools to characterize the chemical and physical properties of small molecules
Demonstrated capability to develop and execute an experimental program
Familiarity with analytical development in the pharmaceutical industry

Intern, Analytical Development Resume Examples & Samples

Candidate must be currently enrolled (and continuing in Fall 2017) in an undergraduate or graduate degree program in a relevant scientific discipline (Chemistry, Biology, Engineering, Physics)
Knowledge and enthusiasm for developing and implementing analytical
Lab techniques needed for chemical analyses
Undergraduate research experience
Some experience operating laboratory instrumentation beyond that gained in general course-work (HPLC,

Director, Analytical Development Resume Examples & Samples

Direct and manage analytical method development and validation at Lexicon’s contract manufacturing organizations
Review quality control documentation in support of drug substance manufacturing at contract manufacturing organizations
Author or update analytical parts of the drug substance section of regulatory submissions
MS or Ph.D. in chemistry or related field
Minimum of 5 years of analytical development experience in a GMP environment
Knowledge of modern analytical technologies, relevant ICH guidelines, project management and Microsoft Office products

Analytical Development Team Leader Resume Examples & Samples

To provide analytical development support for Syngenta customers in Münchwilen and other sites globally
To develop and optimize, together with his/her team, analytical methods for the determination of the assay, level of impurities and stability of active substances, formulations and intermediates
To generate data – following GLP (Good Laboratory Practice) if required - and issuing documents in support of the registration of active substances and formulations (Product Chemistry section)
To lead a team of 2 to 4 analysts
To search for scientific/technical innovation in the area of analytical chemistry and measurement science
A university degree (or equivalent) in Chemistry, Analytical Science or related discipline
Conversant with most modern analytical methods, especially chromatography and spectroscopy
Leadership skills including coaching and influencing competences
Used to work in international project teams
Able to deliver to tight deadlines and being result oriented
Excellent command of English and preferably German

Manager, Analytical Development Resume Examples & Samples

Participate in teams consisting of analytical, manufacturing, process development, quality, regulatory, supply chain, etc. Work with other groups to develop timelines and effective strategies to meet the clinical supply demands and supply chain needs
Provide clear, concise, and timely communications with the internal teams and analytical management
Understand and apply ICH, USP, Ph. Eur., FDA, and other relevant sources of guidance
Author, edit and review sections/documents for regulatory submission: IND and CTAs, and respond to regulatory questions. Support and drive analytical CMC activities using analytical expertise and knowledge of pharmaceutical development process
Work closely with CMO’s and Analytical SMEs to ensure analytical packages are ready in a timely manner
Manage and track the development and qualification of analytical methods
Coordinate the specifications development process, prepare the specification package documents, and drive the process to approve the specifications
Coordinate analytical support for process and formulation development
BS with minimum of 5 years of experience or MS in biology, biochemistry, analytical chemistry or equivalent discipline
Minimum of 3 years of experience in the pharmaceutical industry
Experience in oversight of CMOs for drug substance and drug product manufacturing as well as for method development, characterization and technology transfer preferred
Strong knowledge of analytical chemistry principles
Excellent trouble-shooting capabilities
Experience resolving analytical technical issues

Contractor, Analytical Development Resume Examples & Samples

Protein analytical methods including SDS-PAGE, liquid chromatography and mass spectrometry
Experience in hydrogen deuterium exchange and programming is a huge plus
Candidates should possess excellent communication skills
The ability to learn new techniques and keep accurate lab records
The ideal candidate should have a masters’ degree or PhD in biochemistry or related disciplines with 1-3 years of industrial experience

Intern, Analytical Development Resume Examples & Samples

Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels, as well as all appropriate SOP’s
Develop and maintain working knowledge of commonly used spectroscopic and physiochemical procedures
Assist and analyze samples with the standard procedures effectively and under supervision. Analyze experimental data for validity before reporting results
Use and maintain equipment in a neat and orderly manner. Report any malfunction immediately to supervisor. Repair minor problems. Maintain service and calibration records in accordance with appropriate SOP’s
Submit complete, documented, and legible results of analytical testing. Ensure that data is properly filed and accessible for review in accordance with appropriate SOP’s
Perform other duties as may be reasonably assigned in the course of business
A Chemistry or Biochemistry major, having completed at least sophomore year
Completed analytical coursework
Basic computer skills, like MS Office

Manager, Analytical Development Resume Examples & Samples

Identify new technology and develop strategies to improve workflows associated with the analytical method development and testing for clinical and commercial products
Implement new technologies aimed towards improving laboratory efficiency. These will include laboratory applications that support management of data, e.g., Empower, Electronic Laboratory Notebooks (ELN), and statistical software (JMP)
Deliver the documentation, reports, and summaries necessary for completion of CMC sections of regulatory filings including IND, NDA, and BLA submissions
Ensure application of Quality by Design (QbD) principals to development and validation activities in accordance with FDA initiatives
Manage external testing performed by contract laboratories, ensures project timelines are met and that this testing complies to cGMP requirements
Ph.D./M.S./B.S. in Chemistry, Pharmaceutical Science, or related field; corresponding with 3+/10+/15+ years of pharmaceutical industry experience and 5+ years of team leadership or management experience
Knowledge of regulatory guidelines and strategies for GLP & GMP compliant studies and methodologies needed to establish and/or maintain appropriate clinical and manufacturing controls
Practical knowledge of, and experience in, development and validation of analytical techniques such as; HPLC, GC, Dissolution, spectroscopy, particle size determination, titration, and thermal analysis
Experience writing SOP’s laboratory investigations, out-of-specification and deviation reports, CAPA’s, change controls, and annual product reviews
Experience working with Formulations and/or Process Development is a plus

Manager Analytical Development Resume Examples & Samples

Manage 5-7 direct reports who develop analytical methods for cell and gene therapy
Develop innovative analytical methods that enable automation of testing and increase throughput for determination of product quality
Support external collaborations to enhance our analytical capabilities and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products
Development of analytical method and transfer to internal QC and Process Development laboratories, and CMOs or testing laboratories
Support establishing internal laboratories for analytical development for cell and gene therapy products
Contribute to product specification development
Participate in risk assessments to develop robust product control strategies for cell/gene therapy programs
Responsible for management and successful closure of investigations
Responsible for delivery of relevant sections of regulatory filings and responses to regulatory questions

Senior Analytical Lead-external Analytical Development Resume Examples & Samples

MS +7 years, or PhD +6 years in science or business related or equivalent is required - Advanced degree preferred
Demonstrated expert knowledge and experience NBE analytical plus at least one more area of NBE pharmaceutical development or operations or related field
At least 6 years of supervisory or management experience in technical individuals and programs in different clinical phases
3 or more years’ experience in ‘head of quality control’ role
Strong analytical and problem-solving capabilities and skills
Experience in project and budget planning and execution
Demonstrated communication skills in English

Analytical Lead-internal & External Analytical Development Resume Examples & Samples

Coordinates all NBE Analytical R&D activities related to assigned development projects
MS +7 years, or PhD +4 years in science or business related or equivalent is required - Advanced degree preferred
Demonstrated expert knowledge and experience NBE analytical plus at least 1 more area of NBE pharmaceutical development or operations or related field
At least 5 years of supervisory or management experience in technical individuals and programs in different clinical phases
Experience in a cross-functional, global environment, used to work with teams in a matrix
Excellent understanding of both scientific and regulatory requirements in the area of responsibility

Manager Analytical Development Resume Examples & Samples

Build and lead an analytical method development team comprising of 5-6 direct reports
Develop innovative analytical methods that enable automation of testing and increase throughput for determination of product quality in the cell and gene therapy space
Mentor and coach direct reports and set annual objective and development plans

Senior Manager, Analytical Development Resume Examples & Samples

The Analytical Development (AD) Sr. Manager Operations manages both administratively and technically the operation of the Global Innovation and Development Center (GIDC)- Analytical, Laboratory Information Management System (LIMS) as well as the analytical instrument qualification, calibration and maintenance program
The Sr. Manager Operations provides administrative and technical support to the OpenLAB Enterprise Content Management System or other data management system to ensure cGMP compliance of the AD Laboratory
The Sr. Manager Operations supports AD outsourcing activities of the development site. This may include: document review, assisting with the raw material release, reference standard certification process and addressing OOTs/OOATs and deviations as they may arise
Support new product development by
A Bachelor’s Degree (or international equivalent) in Science, with at least eight years of proven experience or a Master’s Degree (or International equivalent) in Science with at least four years of proven experience or a Ph.D.(or international equivalent) in Science with two years postdoctoral experience
Expert level knowledge of Analytical instrumentation and associated software applications and interfaces. (Demonstrated expert knowledge of Empower is highly preferred)
Proven experience managing the execution of complex projects that require cross-functional team work for execution
Proven ability to effectively coordinate between both internal and external resources cross-functionally across a wide range of scientific disciplines to accomplish objectives
Ability to manage spending to budget targets
Experience in working with purchase order systems is desired
Demonstrated experience in managing compendial and unique raw material programs preferred
Working knowledge of microbiological concepts preferred
Ability to work on multiple projects simultaneously in a fast paced, time constrained and matrixed environment
Strong computer software skills. (Microsoft Office)
Ability to work efficiently and independently
Knowledge of NDA drug and monograph drug development

Director, Biologics Analytical Development Resume Examples & Samples

Create, define, and lead a lab operations function within the analytical development organization to meet the expanding needs of the Celgene Biotherapeutics pipeline
Lead the overall scientific, technical and operational efforts within Analytical Development in regards to functional assay methods qualification and validation
Build the capabilities, and phase appropriate strategies that enable rapid product development and commercialization
Deliver timely data needed to meet Celgene project milestones and associated regulatory requirements. This includes the design of protocols, execution, reporting and approval of qualification reports that support development
Maintain currency with applicable global regulations and industry standards for analytical methods and testing of biological products
Participate effectively in internal development programs and in external collaborations by representing the analytical development organization as needed
Develop the analytical staff to function effectively in cross-functional teams and collaborations
Maintain a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs. Budget and track external expenses for CMO/CRO analytical activities
Participate in CMO/CRO selection, management and auditing as needed
Ph.D. in relevant scientific discipline required
A minimum of 15 years pharmaceutical analytical experience with exposure to all stages of biologics development
Extensive experience in developing cell based bioassays, biacore, Octet, and ELISA based functional assays for measuring relative potency/activity of molecules at all stages of drug development
4Direct experience in CMC analytical and regulatory requirements, including development of product specifications to support early and late stage product development and global commercial registration submissions
Proven leadership ability to align, motivate and empower team members
The ideal candidate will also have experience in interacting with CROs
Demonstrated ability for critical thinking, problem solving and innovation
Strong sense of value of investment and ability to develop cost-effective development plans
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment

Director, Analytical Development Resume Examples & Samples

Defines analytical strategy that is scientifically sound, appropriate and incorporates industry best practices and health authority expectations to support the development of mRNA as vaccines and therapeutics
Work closely with the entire mRNA development team to identify CQAs, analytical methods and develop robust specifications
Defines qualification/validation strategy and writes/reviews associated documents to ensure global compliance for analytical methods including HPLC, LC-MS, Capillary Electrophoresis, ELISA, Bioassay, Spectrophotometric and compendial methods. Manage a team of Research Associates/Scientists to work with QC and CROs to execute method qualification and validation
Conducts periodic review of method validation and performance and work with team to design and execute remediation experiments and implement changes to existing methods
Works collaboratively across organization for method readiness, transfer, performance and troubleshooting to support preclinical and clinical development
Champions high throughput analytical testing approaches via the use of automation and robotics
Manages scientists involved in analytical testing, validation, methods transfer and method lifecycle, including laboratory work as appropriate
PhD in biological sciences, chemistry or related scientific disciplines with a minimum 10-12 years of industry experience in small and/or large molecules drug development
Demonstrated experience with validation, transfer and lifecycle of analytical methods used in biologics process development and/or manufacturing environment
Experience in analytical techniques including UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, and DSC
Prior management and mentorship experience a must
Good understanding of regulatory requirements: ICH, USP/EP/JP etc
Ability to work independently and manage projects in a timely manner
Ability to effectively document and communicate results
Strong interpersonal skills with an eagerness to support colleagues in cross functional teams
(Preferred) Experience in nucleic acid drug development (DNA, RNA, oligonucleotides)
(Preferred) Experience working with both early and late phase drug development programs
(Preferred) Experience working in matrix project teams with members from R&D, partners, CMOs and CROs

Analytical Development Resume Examples & Samples

Responsible for providing analytical support for product development
Responsible for executing the implementation of analytical and analytical method validation projects as defined by the project manager
Conduct of analytical activities as per the predefined protocols for different test parameters and submit the reports
Support for Exhibit batches and commercial OOS and OOT investigations
Responsible for investigating and troubleshooting analytical testing
Supports all aspects of analytical tests including generating documentation, training employees, operating analytical equipment in support of project activities and other activities as required by the project
Generates and / or modifies standard testing procedures, analytical records, special instructions and other related analytical documentation as specific to associated projects
Performs and documents investigations into analytical and analytical method validation events and recommends and implements resolutions
Researches and analyzes data related to analytical operations to suggest improvements and promote efficiency
Adherence to cGMP, SOPs and Regulatory Requirements
Job Location: Hyderabad
Proficiency in speaking, comprehending, reading and writing English is required / preferred

Director, Analytical Development Stability Resume Examples & Samples

Analytical method development and validation of new products
Direct management and of the Laboratory staff
Troubleshooting
Developing stability tests for new products
Responsibility for the development of CMC sections for assigned new products for FDA submission
Assisting in the response to FDA queries regarding new products
Responsibility for GMP compliance of laboratory operations
Supervision, training, and development of the Director’s team
Maintaining audit readiness
Managing of departmental budget
Overnight travel (<10%)

Analytical Development Manager Resume Examples & Samples

To provide leadership and manage all available resources to develop suitably robust methods and including stability
Review and execute a streamlined analytical process to deliver against the Fee For Service and strategic initiatives in product development
Demonstrate strong leadership skills to engage the team, motivating and coaching team members to achieve their potential whilst managing poor performers
Ability to work autonomously including support of multiple projects requiring process development and validation, stability batch release, clinical batch release, analytical method development and analytical method validation
Ensure that good business strategy is followed, dealing with clients directly and manage the associated P&L
Accountable for departmental financial budget
To represent Catalent and R&D at internal and client meetings ensuring effective communications
Has extensive knowledge of use and operation of all commonly used laboratory equipment, including but not limited to chemical, chromatography and physical evaluation of pharmaceutical dose forms
Subject matter expert (SME) and Analytical lead on development projects, including knowledge share and mentoring of all staff
Accountable for the maintaining and monitoring of the stability facilities, ensuring chain of custody of commercial and development products and inventory of the stability chambers

Head of Analytical Development Resume Examples & Samples

Develop, implement, and execute a strategy in-line with the PDTS strategy
Plan, overview, and accountability to ensure execution of all activities related to assay development (process- and product)
Lead and oversee all transfers of analytical methods to internal and external business partners
Own and execute product characterization throughout the lifecycle
Leverage global analytical competencies and capacities across the PDTS network
Develop, implement, and drive execution of PAT strategy
Guide staff in phase-appropriate assay development and qualification, process & product characterization, and application of QbD principles
Deliver robust, reproducible, and compliant assays by application of scientifically sound approaches and methodologies in close cooperation with the quality control teams
Understand the IP landscape around technologies, assays and products. Develop and implement IP strategies in close cooperation with the IP team, to ensure FTO and protect Shire IP and products
Minimize efforts, costs, time related to sampling, testing, and data analysis to increase productivity and decrease COGS without negative impact on quality & regulatory compliance
Accountable for development, implementation, and execution of a technology roadmap in-line with Shires strategy, the R&D strategy, manufacturing strategy, and all PDTS teams
Provide technical input in various governance committees, functional and program decision making bodies
Execute interfaces with process development teams, technical service teams, and CMC teams
Ensure internal and external capabilities, skills, and capacities meet Shires requirements and support uninterrupted supply of commercial products as reasonable cost of goods
CAPEX, OPEX & HC Oversight (budget/forecast)
Manage and oversee all aspects of organizational performance and development within the team incl. HR development, technical performance, and team initiatives
Implement and execute a sourcing strategy in line with Shires strategy and the teams core competencies

Mgr, Analytical Development Resume Examples & Samples

An expert at developing and validating test methods for pharmaceutical raw materials and finished products for strength, impurities, identity and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis
An expert at testing pharmaceutical raw materials and finished products by internally developed and compendial test methods
An expert at troubleshooting analytical and instrument problems and at performing OOS investigations
An expert at GMPs as they pertain to an R&D analytical group and pharmaceutical product development
A strong working knowledge of descriptive organic chemistry
A working knowledge of pharmaceutical formulations development
Managerial
Will be an experienced technical and personal leader, leading by example and making direct reports want to follow
Will be expected to direct the activities of the Analytical Development section in the absence of the Director
Will effectively maintain open communication between AD and internal, as well as external, customers
Will possess teaching skills so that knowledge is passed on to the direct reports
Will be able to manage a growing group of chemists for high levels of efficiency, quality and safety. Will be able to flexibly manage multiple priorities
Will have a strong command of the English language with strong oral and written communication skills
Will have a solid working knowledge of, and experience with, common office software and chromatographic data acquisition systems
Will have experience in providing support for generating CMC sections of INDs, ANDAs and NDAs (including 505b2)
Will be able to effectively work in multidisciplinary teams within the department and company
Ensure that the work performed by direct reports meet pharmaceutical industry and internal company standards for quality and timeliness. Primary duties of direct reports will include the following
Develop and validate methods to test pharmaceutical raw materials and finished products for strength, identity, impurities and dissolution performance by commonly used techniques
Test and release raw materials and finished products in support of internal product development
Test stability samples in support of internal product development
Administrate the departmental cleaning verification program to support the Pilot Plant and the packaging lines
Plan, review and manage the activities performed by direct reports. Such work must meet all appropriate scientific, regulatory and safety standards, including GMPs, ICH, OSHA and internal SOPs
Ensure that all direct reports are properly trained and equipped to perform their assigned duties
Accurately, clearly and completely communicate the results of work, orally and/or in writing, to line management, clients and/or others with a need to know
Work with other sections and department within the company as needed to facilitate the successful development and launch of new products and technologies, and assist in trouble-shooting problems with currently marketed products
Represent the Analytical Development group by participating in departmental and company project teams
Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites
Write SOPs and other instructional documents for the Analytical Development group
This position will report to the head of the Analytical Development group, and will fill in as the acting head of the Analytical Development group in the absence of the head
Help enhance capabilities of the analytical group by appropriate investments in capital and personnel
Help institute new work processes and initiatives to improve efficiency, work flow and turn around time
Ph.D. in Chemistry (a focus on Analytical is preferred) with at least 6 years of directly related experience, including at least 4 years of directly related supervisory experience. (A Ph.D. in Analytical Chemistry with at least 6 years of hands on experience developing and validating chromatographic test methods for pharmaceutical raw materials and finished products, including at least 4 years of supervising/managing a pharmaceutical methods development group is preferred.) Other educational qualifications may be considered if accompanied by additional related experience
Must be fluent in spoken and written English
Must have a working knowledge of common office and technical software
Must be legally eligible to work in the United States and must be able to pass a legally administered drug screening