Sr. Specialist, Aseptic Observation Program
Bristol Myers Squibb · Bothell, WA
CMCFull-time$97k–$117kCompany career page
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Role summary
Bristol Myers Squibb seeks a Senior Specialist for its Aseptic Observation Program in Bothell, Washington. The role involves training, observing, and evaluating aseptic manufacturing practices to ensure regulatory compliance and contamination-free operations. The specialist will document observations, provide coaching, conduct qualifications, and collaborate on process improvements.
What they're looking for
- Bachelor's degree in cell biology, biotechnology, microbiology, life sciences, or equivalent
- Minimum 4 years of relevant experience in biologic or cell therapy manufacturing
- Knowledge of cGMP, GxP, 21 CFR Part 11, GDP, and Annex 1 regulatory requirements
- Cell therapy and aseptic processing experience required
- Excellent observational, documentation, and communication skills
- Ability to work independently and collaboratively in fast-paced environment
- Certification in aseptic processing or quality assurance preferred
What you'll be doing
- Observe aseptic operations including filling, media preparation, and gowning for GMP and SOP compliance
- Document observations in real-time and provide immediate feedback to operators and managers
- Perform staff aseptic processing and gowning qualifications
- Participate in root cause analysis and investigations for aseptic deviations or contamination events
- Support development and delivery of aseptic technique training programs and collaborate with Quality Assurance and Manufacturing teams
Privacy & handoff
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