Training Specialist, Cell Therapy Manufacturing in Devens, MA

Role Summary

Training Specialist, Cell Therapy Manufacturing based in Devens, MA. Focused on delivering training to support the continuous education and technical skill improvement of manufacturing operators in Cell Therapy, with an emphasis on cGMP compliance, safety, and quality.

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 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.

Knowledge and Skills

• 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
• Bachelors in relevant science or engineering discipline, or equivalent in work experience.