The Role
Lead development and scale-up of closed-system adherent cell culture processes to improve yield, quality, and cost. Design and run experiments, mentor junior scientists, manage project teams, evaluate technologies, and collaborate with MSAT, manufacturing, quality, and regulatory to translate discoveries into validated, compliant processes.
Summary Generated by Built In
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.
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.
Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.
Skills Required
- Ph.D. in Cell Biology, Biotechnology, Bioengineering, or related field with 2+ years relevant experience OR MS in Cell Biology, Biotechnology, Bioengineering, or related field with 7+ years relevant experience.
- Hands-on experience in aseptic techniques including mammalian cell and tissue culture with 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.
- Previous experience authoring or reviewing CMC sections of regulatory submissions.
- Familiarity with regulatory requirements for cell therapy products.
- Ability to work in GMP spaces, navigate laboratory/GMP environments, and lift up to 50 pounds.
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The Company
What We Do
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of cell and exosome-based therapeutics. Its lead product candidate, Deramiocel, is an allogeneic cell therapy currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD). The company also leverages its proprietary StealthX™ exosome platform for the targeted delivery of therapeutic agents to treat a wide range of diseases.
