Process Development Scientist - Bioreactor

Responsibilities

• Lead scale-up of cell culture processes using bioreactors with a focus on adherent cell bioproduction.
• Support development and optimization of closed system processes for cell therapy production.
• Design, execution, and interpretation of complex scientific research projects.
• Develop processes to address manufacturing challenges and advance product development.
• Manage scientific aspects of cross-functional teams, ensuring alignment with organizational goals.
• Help mentor and provide leadership to junior scientists.
• Contribute to intellectual property, publications, patents, and present findings at internal meetings as needed.
• Collaborate with MSAT, manufacturing, quality and regulatory teams to translate research into actionable plans.
• Perform other duties as assigned to support process development objectives.

Requirements

• Ph.D. in Cell Biology, Biotechnology, Bioengineering, or a related field with 2+ years of relevant experience or MS in Cell Biology, Biotechnology, Bioengineering, or a related field with 7+ years of relevant experience.
• Hands on experience in aseptic techniques including mammalian cell and tissue culture with a focus on large scale adherent cell culture.
• Demonstrated experience in bioreactor technologies with adherent cell bioreactors preferred.
• Experience designing closed systems and using automated cell processing instrumentation preferred.
• Experience managing junior scientists and collaborating with cross-functional teams.
• Excellent communication and interpersonal skills with the ability to work collaboratively within a team environment.
• Previous experience authoring or reviewing CMC sections of regulatory submissions preferred.
• Familiarity with regulatory requirements for cell therapy products.

Work Environment / Physical Demands

• Primarily laboratory-based, may require time in GMP spaces to aid technology transfers and troubleshooting.
• Requires prolonged periods of computer use for data analysis, documentation, and reporting.
• May involve lifting laboratory materials or equipment up to 50 pounds.
• Ability to navigate laboratory and GMP environments for experiments and coordination.