Aseptic Manufacturing Tech Manager

Bristol-Myers Squibb • Bothell, WA

221d • $113,930 - $138,100 • Hybrid

About The Position

The Manufacturing Aseptic Processing Technical Manager is responsible for leading proactive monitoring initiatives, driving continuous improvement in aseptic techniques, and ensuring compliance with relevant regulations and internal standards. This role requires collaboration with Quality Assurance, Quality Control, MSAT, and Manufacturing Operations to support environmental and personnel monitoring excursion investigations, identify root causes, and implement corrective actions to improve contamination controls within the Cell Processing Facility.

Requirements

• Master's or Bachelor's Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent.
• Minimum of 5 years of relevant experience in biologic or cell therapy.
• Experience in a regulated, GMP manufacturing environment.
• Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1.
• Experience with ergonomics relating to aseptic techniques and aseptic behaviors.
• Experience with electronic quality management systems.
• Experience with cleaning and sanitization practices.
• Familiarity with clean room design and qualification requirements.

Nice To Haves

• Experience with leading change management.

Responsibilities

• Support deviation investigations (environmental monitoring excursions and personnel monitoring excursions) as the manufacturing SME to identify root causes and corrective actions.
• Represent Manufacturing as a decision maker in cross-functional meetings, including IRB, CRB, and CCRB.
• Perform floor gembas to identify gaps in aseptic processing and implement corrective actions to improve aseptic techniques and behaviors, as well as reduce contamination risks.
• Provide on-the-floor process support for validation activities (Aseptic Processing Simulation and Non-Routine Sampling activities).
• Author or review technical documentation (e.g., investigations, change controls, SOPs, impact assessments, batch records, and validation reports).
• Support health authority and/or internal inspections as the aseptic process SME.
• Train end-users and entry-level personnel on the manufacturing process and aseptic techniques and behaviors within the ISO 5/7 (Grade A/B) environment.
• Establish environment and personnel monitoring KPIs and drive Right First Time Reduction.
• Ensure aseptic best practices are embedded with new product introduction technology transfer.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree