The Process Development Scientist at Capricor will lead development of biomanufacturing processes to enhance product yield, quality, and cost-efficiency with a focus on closed system processes and scale-up. This role is responsible for driving process improvements, evaluatingnew technologies, mentoring junior team members, and collaborating with cross-functional teams to translate discoveries into validated processes.
Responsibilities- 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.
- Manage scientific aspects of cross-functional teams, ensuring alignment with organizational goals.
- 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 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
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.
