Process Development Scientist

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

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.