MSAT Training Specialist II/III

Capricor Therapeutics•San Diego, CA

3d•Onsite

About The Position

Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases. The MSAT Training Specialist II/III will be responsible for ensuring operational excellence and GMP compliance in cell therapy manufacturing. This role involves designing and delivering training programs, mentoring manufacturing staff, and maintaining documentation to support regulatory requirements and high-quality production. The ideal candidate will have technical expertise and a commitment to continuous improvement in a dynamic biotech setting.

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.

Nice To Haves

Experience with cleanroom operations and gowning procedures preferred.
Knowledge of cell therapy manufacturing processes preferred.

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.