Supervisor, Aseptic Manufacturing
Core
Oversees aseptic manufacturing production processes for autologous cell therapies, ensuring safety, cGMP compliance, and operational efficiency in ISO class 5 cleanrooms.
Role type
Senior IC manufacturing supervisor (cell therapy)
Builds
TIL cell therapies (e.g., Amtagvi) for cancer patients
Domain
Biopharmaceuticals / Cell Therapy / Immuno-oncology
Required skills
aseptic processing techniques, cGMP compliance, cell culture operations, downstream processing, regulatory knowledge (21 CFR Part 11, FDA), team leadership, SOP development, deviation/CAPA management, technical writing, training program design
Preferred skills
experience in Lead/Supervisory roles, development initiative leadership, mentoring large teams (50+ employees), handling ambiguity, fast-paced environment adaptation
Technologies
ISO class 5 cleanroom environments, half-face respirators, batch record systems, learning management systems
Responsibilities
Supervise and develop direct reports (operators), schedule and coordinate daily activities, review batch documentation and logbooks, oversee manufacturing process adherence to cGMP, author and revise documentation (SOPs, Batch Records, Deviations, CAPAs), conduct performance reviews, ensure compliance with quality standards and safety regulations, work in cleanrooms with biohazards and chemicals, manage training and learning initiatives
Seniority
Senior, hands-on IC