Manager II, Aseptic Observation Program
Bristol Myers Squibb
2 months ago
On-site
Bothell, WA
Operations
Position Summary
- The Aseptic Observation Program (AOP) Manager II provides strategic leadership, governance, and execution of the site Aseptic Observation Program within manufacturing operations.
- Leads a team to train, observe, and evaluate aseptic practices to ensure compliance with regulatory requirements and internal procedures. Collaborates cross-functionally on investigations, drives continuous improvement, and supports aseptic training.
Duties/Responsibilities
- Lead and deploy AOP observers to execute aseptic observations.
- Provide strategic direction and oversight to aseptic observation activities.
- Observe aseptic operations (e.g., filling, media preparation, gowning) for GMP, SOP, and regulatory compliance.
- Document observations in real time; identify areas for improvement.
- Provide immediate feedback and coaching on aseptic technique, gowning, and compliance.
- Partner with QA and Manufacturing leadership on investigations and CAPAs.
- Establish goals, track/report KPIs, and drive continuous improvement.
- Revise documents to improve instructions and training.
- Support development/delivery of aseptic technique training programs.
- Support inspection readiness and regulatory audits as an aseptic SME.
- Maintain detailed observation records and reports; stay current on best practices and regulatory updates.
Qualifications
- Bachelor’s degree (cell biology/biotechnology/biochemistry/microbiology/life sciences or equivalent); 5+ years relevant experience in biologics or cell therapy.
- 1–2 years people/program leadership experience.
- Knowledge of cGMP, GxP, 21 CFR Part 11, GDP, and Annex 1.
- Excellent observational, documentation, and communication skills; works independently and collaboratively.
Required/Preferred Skills
- Certification in aseptic processing or quality assurance.
- Experience with sterile injectable products; electronic quality management systems.
- Knowledge of cGMPs; cell therapy and aseptic processing experience required.
- Preferred: leading change management; experience training/coaching operators; ergonomics related to aseptic techniques; electronic quality systems.
Working Conditions
- Cleanroom with ISO 5/7 (Grade A/B) gowning; stand for extended periods; may work around strong magnets, human blood products (BSL-2), and vapor phase liquid nitrogen.
Benefits
- Health coverage; wellbeing support programs; 401(k); disability and life insurance; paid time off (details provided in posting).
Compensation
- Bothell, WA: $113,140–$137,103 (plus potential incentive cash/stock based on eligibility).
Application Instructions
- Apply even if experience doesn’t perfectly match; compensation and benefits depend on eligibility.
- The Aseptic Observation Program (AOP) Manager II provides strategic leadership, governance, and execution of the site Aseptic Observation Program within manufacturing operations.
- Leads a team to train, observe, and evaluate aseptic practices to ensure compliance with regulatory requirements and internal procedures. Collaborates cross-functionally on investigations, drives continuous improvement, and supports aseptic training.
Duties/Responsibilities
- Lead and deploy AOP observers to execute aseptic observations.
- Provide strategic direction and oversight to aseptic observation activities.
- Observe aseptic operations (e.g., filling, media preparation, gowning) for GMP, SOP, and regulatory compliance.
- Document observations in real time; identify areas for improvement.
- Provide immediate feedback and coaching on aseptic technique, gowning, and compliance.
- Partner with QA and Manufacturing leadership on investigations and CAPAs.
- Establish goals, track/report KPIs, and drive continuous improvement.
- Revise documents to improve instructions and training.
- Support development/delivery of aseptic technique training programs.
- Support inspection readiness and regulatory audits as an aseptic SME.
- Maintain detailed observation records and reports; stay current on best practices and regulatory updates.
Qualifications
- Bachelor’s degree (cell biology/biotechnology/biochemistry/microbiology/life sciences or equivalent); 5+ years relevant experience in biologics or cell therapy.
- 1–2 years people/program leadership experience.
- Knowledge of cGMP, GxP, 21 CFR Part 11, GDP, and Annex 1.
- Excellent observational, documentation, and communication skills; works independently and collaboratively.
Required/Preferred Skills
- Certification in aseptic processing or quality assurance.
- Experience with sterile injectable products; electronic quality management systems.
- Knowledge of cGMPs; cell therapy and aseptic processing experience required.
- Preferred: leading change management; experience training/coaching operators; ergonomics related to aseptic techniques; electronic quality systems.
Working Conditions
- Cleanroom with ISO 5/7 (Grade A/B) gowning; stand for extended periods; may work around strong magnets, human blood products (BSL-2), and vapor phase liquid nitrogen.
Benefits
- Health coverage; wellbeing support programs; 401(k); disability and life insurance; paid time off (details provided in posting).
Compensation
- Bothell, WA: $113,140–$137,103 (plus potential incentive cash/stock based on eligibility).
Application Instructions
- Apply even if experience doesn’t perfectly match; compensation and benefits depend on eligibility.