Cell Therapy Training Specialist

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.

Essential Functions and Responsibilities

• Develops a basic understanding of the current cell therapy manufacturing process and the equipment utilized during processing, as this role is viewed as a subject matter expert (SME) within this specific area.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements; Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• 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.
• Appropriately escalates issues/concerns to Area Management for further investigation.
• Works on assignments that are moderately complex in nature, where judgement is required to resolve or escalate operational issues without negatively impacting manufacturing efforts.
• Complies with Safety SOPs, SDS sheets and laboratory procedures per company policy and OSHA regulations.

Required Education, Skills, and Knowledge:

• 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.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• 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.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity ready to change gears and plans quickly, with the need to manage constant change.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Familiarity with data and sample management required (LIMS/MES).
• Working knowledge within a Learning Management System (LMS).