Director of Cell Therapy Manufacturing
4 days ago
Vericel Corporation is seeking a highly experienced and skilled Director, Cell Therapy Manufacturing to lead our cell therapy manufacturing operations. This is a key leadership role that requires a strong understanding of cGMPs, cell biology, and cell culture, as well as experience in managing aseptic processing and small batch size manufacturing.
Key Responsibilities- Lead and oversee all cell therapy manufacturing operations, ensuring compliance with cGMPs and corporate quality governance.
- Provide guidance and direction to staff, including training, feedback, rewards, and disciplinary action.
- Develop and implement key performance indicators to monitor department performance and identify areas for improvement.
- Collaborate with senior leadership to meet corporate and site goals.
- Oversee failure investigations and ensure appropriate CAPAs are implemented.
- Bachelor's degree in biotechnology, biology, biomedical engineering, or equivalent.
- 10+ years of experience in cGMP biologics, cell therapy, or vaccine manufacturing.
- 6+ years of management experience in a cGMP aseptic processing or similar environment.
- Strong understanding of cGMPs, cell biology, and cell culture.
- Knowledgeable on regulatory requirements and standards affecting Biologics, Medical Devices, and Pharmaceuticals.
- Available for weekend, holiday, and after-hour coverage.
- Ability to gown and gain entry to manufacturing cleanroom areas.
Vericel Corporation is an Equal Opportunity/Affirmative Action Employer and a VEVRAA federal contractor. We are committed to diversity and inclusion in the workplace and welcome applications from qualified candidates of all backgrounds.
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