About Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome‑based therapies for rare diseases. Our lead product, Deramiocel (CAP-1002), is in late‑stage development for Duchenne muscular dystrophy, and we also harness our proprietary StealthX™ exosome platform for targeted delivery and vaccinology.
About the Role
The Process Development Scientist will lead the development of biomanufacturing processes to enhance product yield, quality, and cost‑efficiency, with a focus on scaling cell therapy manufacturing using a bioreactor.
Responsibilities
- Lead scale‑up of cell culture processes using bioreactors with a focus on adherent cell bioproduction.
- Support development and optimization of closed system processes for cell therapy production.
- Design, execute, and interpret complex scientific research projects.
- Develop processes to address manufacturing challenges and advance product development.
- Manage scientific aspects of cross‑functional teams, ensuring alignment with organizational goals.
- Help mentor and provide leadership to junior scientists.
- 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.
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 in bioreactor technologies with adherent cell bioreactors preferred.
- Experience designing closed systems and using automated cell processing instrumentation preferred.
- 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.
Working Conditions
- 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.