Process Development Scientist
On-site · San Diego, California, United States
Job Summary
Lead development and optimization of closed-system cell culture processes with a focus on adherent cell production. Design, execution, and interpretation of complex scientific research projects. Develop processes to address manufacturing challenges and advance product development. Lead and mentor a small project team providing guidance on priorities and technical expertise to ensure deadlines are met. Collaborate with MSAT, manufacturing, quality and regulatory teams to translate research into actionable plans. Contribute to intellectual property, publications, patents, and present findings at internal meetings as needed. Work environment primarily laboratory-based, with potential time in GMP spaces to aid technology transfers and troubleshooting; may involve lifting laboratory materials or equipment up to 50 pounds.
Required Qualifications
- 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 designing closed systems and using automated cell processing instrumentation
- 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
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