Overview
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. 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.
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.
