Capricor Therapeutics
MSAT Training Specialist II/III
San Diego, CA · Mid
Sponsorship not specified$75k-$95kDetected 77 days ago
ExpressRecruitingGMPFDA RegulatoryCell CultureCommunicationCollaborationMentoringRegulatory Affairs
About the role
- Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
- Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
- As an MSAT Training Specialist II/III at Capricor, you will play a pivotal role in ensuring operational excellence and GMP compliance across our cell therapy manufacturing processes.
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.
- 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.
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.
- Advanced knowledge of aseptic techniques, cell counting, and GMP production methods.
- Ability to work independently and in a team in a dynamic setting.
- Primarily laboratory-based with required time in GMP cleanroom environments addressing training and documentation.
- Ability to navigate laboratory and GMP environments for training and oversight.
Nice to have
- Experience with cleanroom operations and gowning procedures preferred.
- Knowledge of cell therapy manufacturing processes preferred.
Compensation
- $75k-$95k
Company info
- 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.
- This position focuses on designing and delivering robust training programs, mentoring manufacturing personnel, and maintaining documentation that supports regulatory readiness and high-quality production.
- Ideal candidates thrive in a dynamic biotech environment, combining technical expertise with a commitment to continuous improvement and team development.
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This listing is sourced directly from Capricor Therapeutics's careers page and normalized into a canonical job model.