Process Development Scientist Job Description
Process development scientist
provides organic chemistry expertise, technical leadership, and support cross-functional research activities as needed, communicate project status and effectively provide technical explanation/rationalization.
Process Development Scientist Duties & Responsibilities
To write an effective process development scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included process development scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Implementation, validation, and documentation of new cell processing methods
Process translation and automation
Interaction with subject matter experts
Support of ongoing process development and automation activities
Work with team in the design and optimization of purification steps for glycoconjugates or other macromolecular vaccines using technologies such as filtration (normal/tangential flow), chromatography
Require a strong knowledge of the principles of process development and have strong documentation and communication skills
Responsible activities would include process development of cosmetic and OTC Monograph drug products and providing hands on technical support in the design, development, and the implementation of new products, existing products process improvement and resitings for products manufactured within the Neutrogena Los Angeles Manufacturing Facility
Write and/or review process development documentation (e.g., process development summary reports and Manufacturing Work Instructions)
Responsible to execute and review laboratory work, study and trial protocols, and reports to support process development
May lead project teams and provide technical mentorship to junior level scientists and also have oversight for Contractors working in Process Development
Process Development Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Process Development Scientist
List any licenses or certifications required by the position: PMP
Education for Process Development Scientist
Typically a job would require a certain level of education.
Employers hiring for the process development scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Chemical Engineering, Biochemistry, Engineering, Biology, Biotechnology, Science, Manufacturing, Biological Sciences, Life Sciences
Skills for Process Development Scientist
Desired skills for process development scientist include:
GMP/GLP regulations in cGMP/cGLP manufacturing environment
Excel
Organic chemistry
Pharmaceutical/biotech processes
PowerPoint
ChemDraw
Microsoft Excel
Organic chemistry and chemical safety
SciFinder
Cell biology
Desired experience for process development scientist includes:
Expert knowledge of the principles of molecular biology, biological process engineering and related natural sciences
Frequently grasp lightly/fine manipulation, perform desk-based computer tasks, lift/carry/push/pull objects that weigh up to 10 pounds
Occasionally stand/walk, sit, twist/bend/stoop/squat, grasp forcefully
Rarely kneel/crawl, climb (ladders, scaffolds, or other), reach/work above shoulders, use a telephone, writing by hand, sort/file paperwork or parts, operate foot and/or hand controls, lift/carry/push/pull objects that weigh >40 pounds
A background in polymer/material science
Experience with UV/Vis and/or fluorescence spectroscopy is preferred
Process Development Scientist Examples
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Process Development Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of process development scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for process development scientist
- The position may be field based in either San Francisco area, with primary responsibilities in the local area and a requirement to travel as needed on the West Coast to balance project responsibilities with the pre-existing California field scientist team
- Designing new or refining existing processes to optimize manufacturing using lean and six sigma methodologies
- Executes responsibilities with a large degree of urgency and autonomy requiring minimal oversight by immediate manager
- Reading and writing technical reports
- Working with product development teams at various stages of development
- Work with multi-functional teams to identify and implement improvements with new technologies that will boost product quality, yields, and reduce production costs
- Synthesize conjugated polymers using standard air-sensitive techniques
- Identify process gaps, and develop in-process and end-of-process analytical methods for evaluating product quality
- Apply an advanced knowledge of biological manufacturing science in the design and execution of bioreactor experiments to identify and validate critical parameters that affect upstream bioprocess performance across multiple scales
- Work in collaboration with colleagues in pilot and manufacturing scale operations to devise scale-up strategies for fermentation processes
Qualifications for process development scientist
- Positive attitude and ability to work well with others as a technical lead, seeks new opportunities as time allows
- Ability to understand complex problems and to collaborate and troubleshoot alternative solutions
- Ability to organize and prioritize own work schedule on longer-term basis (longer than one month)
- Ability to orally communicate technical information
- Ability to compose materials such as detailed reports and work-related SOPs, and/or to make presentations outside the immediate work area
- Ability to plan, schedule and carry out work for successful project completion, while integrating timelines, devising batch records and meeting milestones
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Process Development Scientist Job Description
Job Description Example
Our growing company is looking to fill the role of process development scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for process development scientist
- Develop analytical methods for the reagents and protein characterization that will correlate with performance on our sequencing platform
- Help develop analytical methods for the reagents and protein characterization that will correlate with performance on our sequencing platform
- Designs, monitors or conducts experimental strategies with general guidance from supervisor
- Keeps current in field of scientific expertise and areas relevant to their function
- Monitors field of expertise, including literature and technology development, and communicates relevant observations
- May introduce advanced scientific methods
- Develops and implements new and novel protocols to address specific issues
- May represent the department on project teams under supervision of a senior scientific staff member
- May initiate productive collaborations within and outside of the department or company
- Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents
Qualifications for process development scientist
- Ability to make presentations, inside and/or outside the organization
- Ability to utilize MS-Office to perform basic calculations, tabulate data and prepare data
- BS with 8+ years of industry experience or MS with 4 years of industry experience in Biology, Biochemistry, Chemical Engineering or a related discipline
- Experience and/or training in process chromatography, ultrafiltration / diafiltration, and other separation technologies is required
- Enthusiasm, flexibility and the desire to work with a variety of teams in a multi-tasking environment
- Strong interpersonal skills and an entrepreneurial spirit
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Process Development Scientist Job Description
Job Description Example
Our growing company is looking for a process development scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for process development scientist
- Work cross-functionally with scientists and engineers to coordinate quality control efforts
- A track record in the development/scale-up of biologics
- Experience of in-process analytical methods and determining critical process parameters (CPP) ideally for viral vectors
- Experience of process transfer and cGMP manufacturing would be an advantage
- Developing processes and completing external (to and from client) and internal (to cGMP manufacturing department) technical transfers of downstream unit operations
- Transferring processes to cGMP manufacturing
- Designing and executing downstream development studies including cell harvest clarification, chromatography, filtration, viral filtration, depth filtration, UFDF, membrane chromatography
- Evaluating and developing new downstream production technologies, particularly to support conversion of unit operations to single-use disposable systems
- Supporting the BMS Marketing team
- Represent the Monoclonal Antibody preparation group on interdisciplinary project teams
Qualifications for process development scientist
- Develop test protocols and present detailed reports to customers
- Produce publication quality written experimental reports and other appropriate documentation
- The candidate must have well-developed verbal and written communication skills and the ability to respond in a timely fashion
- Exposure to and awareness of external scientific field and trends as they relate to biologics process development
- Experience in preparative purification of proteins, viruses, VLPs, and/or other biological molecules
- Technical background in chromatography, membrane filtration operations, and common biochemical analytical techniques
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Process Development Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of process development scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for process development scientist
- Performs data acquisition and analysis in a timely manner
- Documents work appropriately in lab notebooks and technical memos
- Maintains and evaluates lab equipment and optimizes lab operations for efficient use of time and resources
- Assists in troubleshooting and solving technical problems
- Assists in technical transfer to manufacturing or quality control
- Assists in manufacturing support and troubleshooting
- Prepares and delivers comprehensive technical presentations
- Performs routine and complex tasks independently
- Understands and adheres to corporate standards regarding code of conduct, safety, and GMP compliance
- Your technical background and knowledge on qualification and validation will be put to use in a variety of projects and in the lab
Qualifications for process development scientist
- Experience installing, maintaining, and operating fermentation and/or cell culture process equipment including stirred tank fermentors and/or cell culture bioreactors, roller bottles or cell factories, and TFF cell harvest equipment
- Experience with New Brunswick stir tank bioreactors or Sartorius tank and rocking motion bioreactors preferred
- Experience with GMP manufacturing of human drug products preferred
- Has ability to apply scientific or engineering principles, established GMP techniques, and company’s policies and procedures in completion of job tasks
- Takes initiative in keeping current in area of specialization (e.g., chromatography, filtration)
- BS in pharmacy/pharmaceutical science, chemical engineering, chemistry, health sciences, or related field with 5+ years of process development/validation experience or MS/PhD with a minimum of 3+ years of experience
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Process Development Scientist Job Description
Job Description Example
Our company is looking for a process development scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for process development scientist
- Effectively communicates with clients and vendors
- Must have laboratory skills in protein purification and chromatography
- Support the characterization and purification of biologics via protein purification, filtration methods, and chromatography techniques
- Assist in the preparation of buffers and columns
- Contribute to planning and design of experiments, execution and analysis of data
- Maintain proper documentation of experimental results as per GLP standards within existing quality system
- Populate and maintain additional databases that support sample submission, data coordination, test scheduling, and inventories
- Interacts internally with Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups
- Operate and maintain laboratory automation equipment (Tecan, Hamilton, Ambr15, Ambr250, CompacT, and/or HighRes Biosolutions) to support HTPD screening experiments
- Perform analytical testing, including cell-based assays, biochemical testing, and/or HPLC to support HTPD experiments, and participate in development of new assays as needed
Qualifications for process development scientist
- Desired to have experience with PLC controlled equipment’s
- Exposure to the entire NPI platform from product definition to the final phase of product release
- Experience with protein analytical methods such as IEX, SEC, RP_HPLC, glycan analysis, UV spectrophotometry, preferred
- Minimum of MS degree in chemistry/material science/chemical engineering with 10 years of industry experience in process development or Ph.D
- Be well organized, have multi-task project experience, and be able to communicate and work well with other departments
- A degree in Chemical/Biochemical Engineering, Biochemistry, Biophysics or equivalent