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Job description
Role
Manufacturing Team Lead for Liso-cel CAR-T cell therapy production, overseeing GMP manufacturing processes in a controlled cleanroom setting.
Responsibilities
manage equipment setup and operation for blood component manufacturing
lead deviation investigations
ensure timely closure of CAPAs
maintain aseptic techniques
record production data in compliance with GDPs
support continuous improvement initiatives
Requirements
Bachelor's degree with 2-4 years of cell therapy or biopharmaceutical manufacturing experience (or related technical degrees with more extensive experience)
knowledge of cGMP/FDA regulations
aseptic qualification
proficiency in technical writing and MS Office
Preferred
experience with cell culture, cryopreservation, and biologics manufacturing
High-value details
focus on cell therapy (Liso-cel CAR-T)
cGMP environment
blood component processing
cross-functional team collaboration
Work schedule & location
The role involves shift-based work (night shift, Wednesday-Saturday) onsite in NJ, with physical and environmental requirements typical of a sterile manufacturing environment.
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Worksite address
summit, NJ, 07902, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.