MSAT Training Specialist 2/3

Salary Range: 75000 to 95000 (Currency: USD) (Pay period: per-year-salary)

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.