Senior Manager of Cell Therapy Manufacturing
vor 2 Monaten
Bristol Myers Squibb is seeking a highly skilled and experienced professional to join our team as a Senior Manager of Cell Therapy Manufacturing. This role will be responsible for supporting the production of personalized cell therapy products at Contract Manufacturing Organizations (CMOs) for both global clinical trials and commercial supply.
Key Responsibilities- Provide technical support and guidance to CMOs on manufacturing processes and procedures.
- Lead manufacturing investigations and implement corrective actions to ensure compliance with regulatory requirements.
- Develop and maintain process documentation, including SOPs, change controls, and validation documentation.
- Collaborate with cross-functional teams to ensure technical support is delivered to a rapidly growing CAR-T manufacturing organization.
- Ensure the manufacturing process is in a state of control through the understanding of Continued Process Verification (CPV) data.
- Perform and support data monitoring of manufacturing processes to understand process capability, resolve production issues, and troubleshoot investigation-driven events.
- Bachelor's Degree in science or engineering.
- Eight (8) or more years of manufacturing support or related experience in the biopharmaceutical industry.
- Mastery of SOPs and cGMPs and the know-how to work and manage within a regulatory environment.
- Experience with Lean Six Sigma projects, Cellular therapies, process validation, in-depth manufacturing systems is strongly preferred.
- Experience with regulatory agency inspections and regulatory responses is a plus.
Bristol Myers Squibb offers a dynamic and inclusive work environment, with opportunities for professional growth and development. We are committed to diversity, equity, and inclusion, and strive to create a workplace where everyone feels valued and respected.
We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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