Sr. Specialist, Aseptic Observation Program

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.

Responsibilities

• 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

Requirements

• 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

Compensation: $96,832 - $117,338