Senior Specialist, MSAT Investigations
Bristol Myers Squibb · Leiden, Netherlands
CMCFull-timeCompany career page
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Role summary
Bristol Myers Squibb seeks a Senior Specialist for MSAT Investigations at its Leiden Cell Therapy Facility. The role provides investigation leadership, conducting root cause analyses and managing corrective actions to ensure compliant cGMP operations in cell therapy manufacturing.
What they're looking for
- Bachelor's degree in science, engineering, biochemistry, or related discipline
- 2-4 years' experience in biopharmaceutical operations or equivalent
- Root cause analysis and OPEX tools experience preferred
- Cell therapy, biologics, or vaccine manufacturing experience desired
- cGMP and multi-national biopharmaceutical regulations knowledge desired
- Excellent verbal and written communication skills
- Ability to influence at all organizational levels and prioritize in dynamic environments
What you'll be doing
- Conduct and manage root cause investigations as Lead Investigator with impact assessments and CAPAs
- Collaborate with Process Engineering, Manufacturing Operations, Quality Assurance, and Quality Control teams
- Drive timely investigation and CAPA closure according to established KPIs
- Present investigation findings to stakeholders and senior management
- Apply Quality Risk Management and Operational Excellence principles to support continuous improvement
Privacy & handoff
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