Senior Specialist, MSAT Validation & LCM
Bristol Myers Squibb · Leiden, Netherlands
CMCFull-timeCompany career page
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Role summary
Bristol Myers Squibb seeks a Senior Specialist for process validation and lifecycle management at its Leiden Cell Therapy Facility. The role supports validation activities for new products, manages aseptic process simulations, and implements regulatory-compliant manufacturing changes across the site.
What they're looking for
- Bachelor's degree in science, engineering, biochemistry, or related field; advanced degree preferred
- Minimum 5 years' experience in biopharmaceutical operations or equivalent
- Proficiency in cGMP regulations and multi-national biopharmaceutical/cell therapy regulatory requirements
- Experience with facility/clean room design, process validation, equipment, and automation
- Demonstrated experience with health authority audits and pre-licensure inspections
- Strong verbal and written communication skills with ability to influence across organizational levels
What you'll be doing
- Support validation activities for new products and processes including aseptic process simulations and process performance qualifications
- Perform statistical data analysis and prepare protocols, reports, and summaries for validation studies
- Design and execute test plans and risk mitigation exercises including root cause analyses and corrective actions
- Lead site change controls and support implementation of lifecycle management changes
- Participate in facility commissioning, qualification, and risk assessments while maintaining regulatory compliance
Privacy & handoff
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