The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required.

Duties:

• Presents and delivers content to manufacturing technicians.
• Assists with the creation, review and improvement of designated training scripts; On the Job and Instructor Led Trainings (OJTs and ILTs).
• Supports management with the alignment of manufacturing processes with technical training, ensuring consistency.
• Helps to identify training needs; assists in establishing a feedback loop to ensure continuous improvement.
• Assists with drafting SOPs, Batch Records, Deviations, CAPAs, etc. Performs revisions as needed to accurately reflect current procedures.

Qualifications:

• Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience
• Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture.
• Technical knowledge of aseptic processing in cleanroom environments is a must.
• Knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning and qualification is a must.
• Experience leading “development” initiatives such as training, coaching/mentoring, learning initiatives.
• Ability to mentor and provide best practices to new employees.
• Experience with Master Control a plus