Process Development Scientist
$120k - $140kCapricor Therapeutics, Inc.
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
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. 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.
- 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
- 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.
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