Training Specialist, Cell Therapy Manufacturing - Devens MA

Responsibilities

• Demonstrates the ability to execute operations as described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Completes documentation required by training policies and standard operating procedures.
• Performs and demonstrates tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Qualifies new employees on assigned curriculum required of their job functions.
• Executes trainee requalification’s as needed.
• On-time completion of training assignments to ensure technical skills and knowledge are adequate prior to the training of other individuals.
• Collaborates with support groups on recommendations and solving training gaps between new hire onboarding and the transition to manufacturing operations.
• Identifies innovative solutions.
• Supports creation of manufacturing training materials such as On-The-Job-Trainings and Instructor-Led-Trainings.
• Works independently and escalates issues appropriately, works with Management to resolve.

Requirements

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing preferred.
• Must be able to gown into a cleanroom environment.
• Must be able to be near strong magnets.
• Experience with delivering training to adult learners and groups.
• Experience and knowledge of Cell Therapy operations preferred.
• Communicates effectively between peers, trainees, and cross-functional stakeholders.
• Ability to work collaboratively with all employees at all levels.
• Demonstrates strong problem solving and critical thinking skills.

Qualifications

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelor's degree in relevant science or engineering discipline, or equivalent in work experience.