Responsibilities
- Develop and deliver training sessions on GMP cell culture manufacturing, cell counting, and aseptic techniques.
- Design and implement innovative training modules and programs to enhance engagement and retention.
- Collaborate with subject matter experts to align training materials with regulatory standards.
- Mentor and coach manufacturing personnel, fostering a culture of continuous growth and strict GMP adherence.
- Oversee the creation, review, and maintenance of SOPs, batch records, and technical documents for training and compliance.
- Lead investigations, interviews, root cause analyses, and impact assessments for deviations, CAPAs, and change controls.
- Manage the training lab, ensuring it is fully equipped, stocked, and prepared for all training activities.
- Partner with Quality Assurance, Manufacturing, and Regulatory Affairs to integrate training with operational and compliance workflows.
- Monitor and evaluate training effectiveness using feedback, performance metrics, and audits to drive continuous improvement.
- Stay current with industry trends, regulatory changes, and best practices.
Requirements
- Bachelor’s degree in a life science discipline (e.g., Biology, Biotechnology) or equivalent experience.
- 3-7 years of experience with mammalian cell culture manufacturing in a GMP environment.
- Proven expertise as a Subject Matter Expert or Trainer in GMP cell culture manufacturing.
- Extensive experience authoring and reviewing SOPs, batch records, and technical documents.
- Advanced knowledge of aseptic techniques, cell counting, and GMP production methods.
- Communication and presentation skills for diverse audiences.
- Exceptional communication skills and attention to detail for training materials and records.
- Ability to work independently and in a team in a dynamic setting.
- Experience with cleanroom operations and gowning procedures preferred.
- Knowledge of cell therapy manufacturing processes preferred.
Work Environment & Physical Demands
- Primarily laboratory-based with required time in GMP cleanroom environments addressing training and documentation.
- Requires prolonged periods of standing, computer use for training materials, and gowning for cleanroom work.
- May involve lifting materials or equipment up to 20 pounds.
- Ability to navigate laboratory and GMP environments for training and oversight.
Why Capricor?
Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.
Come Work With Us
At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.
Recruiting Fraud Notice
Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.
Skills Required
- Bachelor's degree in a life science discipline or equivalent experience
- 3-7 years of experience with mammalian cell culture manufacturing in a GMP environment
- Proven expertise as a Subject Matter Expert or Trainer in GMP cell culture manufacturing
- Extensive experience authoring and reviewing SOPs, batch records, and technical documents
- Advanced knowledge of aseptic techniques, cell counting, and GMP production methods
- Communication and presentation skills for diverse audiences
- Exceptional communication skills and attention to detail for training materials and records
- Ability to work independently and in a team in a dynamic setting
- Experience with cleanroom operations and gowning procedures preferred
- Knowledge of cell therapy manufacturing processes preferred
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.
