Role OverviewAs a Sr. Product Specialist Cell Therapy Cell Culture, you will be responsible for the clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module (CTMOD). You will collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.
What You Will Do
Your primary responsibilities will include manufacturing products across various phases of the product life cycle, developing training curricula, delivering SME training, and ensuring adherence to cGMP and internal standards.
Why It Might Be a Fit
We seek an incumbent who possesses expertise in end-to-end cell culture operations, strong understanding of cGMP regulations, and proficiency in using data analysis tools to monitor and troubleshoot manufacturing processes.
Requirements
- Bachelor's degree in a relevant life science or engineering discipline
- 5–7 years of relevant experience in cell therapy, biologics, or advanced therapy medicinal product (ATMP) manufacturing
- Hands-on experience with mammalian cell culture and aseptic processing in a cGMP environment
- Strong understanding of cGMP regulations, quality systems, documentation practices, and compliance expectations for clinical and launch-stage products
Benefits
- Health care
- Vision
- Dental
- Retirement
- PTO
- Sick leave
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