Contract Associate Scientist/Scientist, Process Development

This role is responsible for providing overall support in early stages of process development and acting as an interface with the Research and CMC organizations.   The Scientist is responsible for  projects focused on developing, optimizing, and scaling cell lines and fed-batch processes for biologics manufacturing and other applications. The Scientist will also be involved in tech transfer activities for external manufacturing.

Primary Responsibilities:

• Determination of critical process parameters, and developing robust, industrial processes for cell culture production of protein derived from mammalian cell lines for cGMP implementation
• Experience with and cell culture scale up/down and process characterization
• Experience delivering material suitable for toxicology studies to support regulatory filings
• Leading development, hands-on execution, and optimization of protein expression including cell culture from microplate to , familiarity with cell banking, comprehension of manufacturing processes (specifically batch and fed-batch) and harvest of material at required scales.
• Participating in scale-up and tech transfer of protein expression processes for external manufacturing under various regulatory systems (e.g. ISO13485, cGMP).
• Data analysis and authoring key documents such as development reports and technology transfer packages.
• Participating in cross-functional project teams and communicating data, results, and conclusions to scientists, project management, business development, and other stakeholders.
• Ensure a continuous improvement within Upstream process development activities
• Execute routine scale down protein expression using benchtop bioreactors to optimize protein expression processes
• Provide expertise and insight to guide development of appropriate expression methods
• Perform, develop and optimize robust, efficient, scalable strategies for improving process performance
• Activities will include small-scale studies and pilot scale expression studies
• Apply DOE methods to expression activities
• Mentoring junior Associates or Co-Ops and helping them in their planning and activities.

Qualifications:

• B.S. in Biology, Biochemistry, Biomedical Engineering, or an equivalent engineering/science degree with 2-4 years of experience working in the Biopharma industry
• Strong hands-on experience in troubleshooting and routine instrument maintenance
• Upstream processes at the small to an intermediate scale of cGMP biologics production.
• Process scaling and/or technology transfer.
• Authoring and executing protocols, interpretation of data, and report generation.
• Operating and troubleshooting process equipment.
• Ability to work independently and as part of a cross-functional team
• Ability to adapt to frequent change and thrive in a dynamic early-stage environment
• Strong communication and organization skills, strong knowledge of MS Office, data plotting and graphing software. Must be able to communicate results effectively. Experience using electronic lab notebooks preferred.