Process Development Scientist

Capricor TherapeuticsSan Diego, CA
Onsite

About The Position

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, evaluating new technologies, mentoring junior team members, and collaborating with cross-functional teams to translate discoveries into validated processes.

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.

Nice To Haves

  • Previous experience authoring or reviewing CMC sections of regulatory submissions preferred.
  • Familiarity with regulatory requirements for cell therapy products

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.
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