Manager, Contamination Events & Sterility Assurance Support

Bristol Myers Squibb • Devens, MA

2d • $109,050 - $145,354 • Hybrid

About The Position

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Requirements

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• Minimum 3 years (B.S.) or 1 year (M.S.) of experience in microbiology, sterility assurance, quality, or aseptic manufacturing within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Foundational knowledge of aseptic processing principles, environmental monitoring programs, and sterility testing (e.g., USP <71>, <1116>).
• Experience contributing to GMP impact assessments and deviation/CAPA documentation in a regulated manufacturing environment.
• Familiarity with applicable regulatory requirements including FDA 21 CFR Parts 210/211, EU GMP Annex 1, and USP microbiological chapters.
• Strong attention to detail, data integrity awareness, and technical writing ability for GMP documentation.
• Effective collaborator with the ability to work across functions and communicate clearly with both technical and quality stakeholders.
• Experience with environmental monitoring (EM) data trending and excursion investigation.
• Exposure to aseptic process simulations (media fills) and associated investigation activities.
• Familiarity with contamination control strategy (CCS) concepts and EU GMP Annex 1 (2022 revision).
• Experience supporting quality risk assessments at External Manufacturing partners from a microbiology or quality perspective.
• Proficiency with quality management systems (e.g., TrackWise, Veeva Vault) for deviation and CAPA management.
• Knowledge of risk management principles (ICH Q9) as applied to sterile manufacturing environments.
• Scientific curiosity and analytical thinking; ability to work through complex, data-rich problems with support from senior colleagues.
• Clear and concise written and verbal communication skills for GMP documentation and cross-functional collaboration.
• Strong organizational skills with the ability to manage multiple investigations and deliverables simultaneously.
• Growth mindset and eagerness to develop deep technical expertise in aseptic manufacturing and sterility assurance.
• Commitment to quality, data integrity, and patient safety in all activities.

Nice To Haves

• M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Responsibilities

• Support microbiological and aseptic process impact assessments for investigations at BMS internal manufacturing sites, including environmental monitoring (EM) excursions, bioburden failures, sterility test failures, and aseptic process deviations.
• Evaluate root cause analyses (RCA) and contribute to assessment of product, process, and patient impact under the guidance of senior scientists.
• Author and contribute to impact assessment documentation, deviation records, and CAPA review in compliance with BMS quality systems and regulatory standards.
• Support timely completion of impact assessments, tracking action items and CAPA effectiveness in collaboration with site Investigation Leads.
• Assist in monitoring and trending of microbiological data (EM, utility monitoring, sterility testing) to identify potential contamination signals and systemic issues.
• Collaborate with site Microbiology, Quality, MS&T, Manufacturing, and Validation teams to gather data and support impact assessment activities.
• Support preparation for regulatory agency inspections and internal audits by organizing impact assessment documentation and providing technical input as needed.
• Assist senior MQSA team members in the review and assessment of sterility and microbiological investigation impact assessments submitted by ExM partners (CMOs/CDMOs).
• Provide technical input on ExM impact assessment quality and RCA adequacy, escalating gaps or risks to the Principal Scientist or Sr. Director.
• Support quality risk assessments at CMOs, contributing to periodic risk reviews of aseptic processing operations and contamination control programs.
• Support periodic trend reviews of ExM microbiological data and investigation metrics, contributing to risk-based oversight activities.
• Participate in remote or on-site technical interactions with ExM partners as needed, building knowledge of external site operations and capabilities.
• Provide scientific support for aseptic processing activities including environmental monitoring program reviews, cleanroom classification, and gowning qualification.
• Contribute to contamination control strategy (CCS) development and maintenance activities in alignment with EU GMP Annex 1 (2022) and ICH Q9 principles.
• Support aseptic process change control reviews by providing microbiology and sterility assurance input on proposed changes to operations, equipment, or environments.
• Assist in the evaluation and implementation of cGMP improvements related to aseptic processing, sterility assurance, and environmental monitoring.
• Contribute to the development and maintenance of MQSA standard operating procedures (SOPs), guidance documents, and training materials.
• Stay current with evolving regulatory guidance (e.g., EU GMP Annex 1, FDA Aseptic Processing Guidance, USP chapters) and share learnings with the team.
• Participate in cross-functional project teams, working groups, and forums related to sterility assurance and microbiology.
• Actively develop technical expertise in aseptic manufacturing, contamination control, and investigation methodology through on-the-job experience and professional development.

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays
• 160 hours of paid vacation annually for new hires
• 3 optional holidays
• paid sick leave
• up to two paid volunteer days per year
• summer hours flexibility
• leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
• annual Global Shutdown between Christmas Day and New Year's Day

What This Job Offers

• Job Type: Full-time
• Career Level: Manager