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Manager II, Aseptic Observation Program
$113,140–$137,103 year
On-site · Bothell, Washington, United States
Job Summary
The Aseptic Observation Program (AOP) Manager II leads strategy, governance, and execution of the site Aseptic Observation Program within manufacturing. Responsibilities include deploying AOP observers to perform aseptic observations, providing strategic direction, coaching operators on aseptic technique, documenting observations, and driving continuous improvement. Partners with QA and Manufacturing on investigations and CAPAs, tracks KPIs, supports training and inspections, and stays current with regulatory updates. Requires a Bachelor's degree in life sciences and 5+ years in biologics/cell therapy with 1–2 years of people/program leadership, knowledge of GMP/GxP and 21 CFR 11, and strong observational and documentation skills.
Required Qualifications
- Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent
- minimum 5 years of relevant experience in biologic or cell therapy
- 1 – 2 years leadership experience in people or program leadership
- Knowledge of regulatory requirements including cGMP, GxP, 21 CFR Part 11, GDP, and Annex 1
- Excellent observational, documentation, and communication skills
- Ability to work independently and collaboratively in a fast-paced environment
- Experience with training or coaching operators is a plus
- Experience with electronic quality management systems
- Experience with cleaning and sanitization practices
- Cell therapy and aseptic processing experience required
- Ability to collaborate and influence cross-functional teams
- Experience with leading change management preferred
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