Associate Director Cell Therapy QA External Drug Product Quality Specialist
vor 2 Wochen
Bristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy Quality Assurance team in a key role that will drive the quality of our external drug product manufacturing operations.
About the RoleThis is a unique opportunity to work in a dynamic and innovative environment, collaborating with cross-functional teams to ensure the quality of our cell therapy products. As an Associate Director, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for commercial and clinical CAR T products in Europe.
Key Responsibilities- Provide Quality oversight of CMOs performing critical manufacturing steps for commercial and clinical CAR T products in Europe.
- Take responsibility of QA lead function in cross-functional VPT team and acting as central point of contact for all Quality related topics in relation to the assigned CMO for internal and external stakeholders.
- Represent the organization in internal management reviews and take accountability for CMO related metrics, issues, and projects.
- Responsible for Quality Review meetings with internal and external management.
- Act as Quality lead in Technology Transfer from internal sites to CMO and/or key projects related to manufacturing process like expansions, ramp up or major process changes.
- Master's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.
- Min. 10 years EU GMP regulated industry experience with a minimum of 5 years' experience in quality assurance and/or compliance.
- Strong knowledge of relevant regulations and guidance for ATMP.
- Expertise in Transfer Projects (e.g. Tech Transfer, Analytical Method Transfer)
- Fluent in English, and preferably local language of CMO
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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Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleWe are seeking a highly experienced and skilled Associate Director to join our Cell Therapy QA External Drug Product Quality team at Bristol Myers Squibb. As a key member of our organization, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy QA External Drug Product Quality team.About the RoleThis is a unique opportunity to work in a cross-functional team,...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy Quality Assurance team in a key role that will drive the quality of our external drug product manufacturing...
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