Manager II, Aseptic Observation Program

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position SummaryThe Aseptic Observation Program (AOP) Manager II is accountable for the strategic leadership, governance, and execution of the site Aseptic Observation Program within manufacturing operations.The AOP Manager will lead a team responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing timely feedback on aseptic techniques, behaviors, and processes. The Manager II will collaborate with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives.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) to ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements.• Document observations in real-time and areas for improvement.• Provide immediate feedback and coaching to operators and managers regarding aseptic technique, gowning, and compliance.• Partner with Quality Assurance and Manufacturing leadership on investigations and CAPAs• Establish department goals, tracks and reports KPIs, and drives continuous improvement efforts.• Performs document revisions as needed to improve instructions and training.• Support the development and delivery of aseptic technique training programs.• Support inspection readiness and regulatory audits as an aseptic SME• Maintain detailed records and reports of observations, findings, and recommendations.• Stay current with industry best practices, regulatory updates, and trainings related to aseptic processing.• May support APS, CRC, and EMPQ activities through aseptic observations.Reporting RelationshipSr. ManagerQualificationsEducation/Experience:• Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 5 years of relevant experience in biologic or cell therapy.• 1 – 2 years prior people or program leadership experience• Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (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 ergonomics relating to aseptic techniques and aseptic behaviors.• Experience with electronic quality management systems.• Experience with cleaning and sanitization practices.Skills & Abilities:• Certification in aseptic processing or quality assurance.• Experience with sterile injectable products.• Experience with electronic quality systems.• Knowledge of cGMPs. Cell therapy and aseptic processing experience is required.• Ability to collaborate and influence cross-functional teams.• Experience with leading change management is preferred.WORKING CONDITIONS:• Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B).• Must be able to stand for extended periods of time.• Work in areas that may have strong magnets.• Work in areas where handling human blood products (Biosafety Level 2) may be required.• May work in areas with exposure to vapor phase liquid nitrogen.• Must be able to gown in and be present in the Grade A/B environment for extended periods of time.BMSCART#LI-ONSITEIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Bothell - WA - US: $113,140 - $137,103 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:Health Coverage: Medical, pharmacy, dental, and vision care.Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, acciden