Manager, Contamination Events & Sterility Assurance Support

Manager, Contamination Events & Sterility Assurance Support

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.

Key Responsibilities Investigation Impact Assessment Internal Sites

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.

External Manufacturing ( ExM ) Support

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.

Aseptic Process Support

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.

Technical Contribution & Development

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.

Qualifications & Experience Education

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Experience

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.

Skills & Competencies

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.

Travel

This position requires up to 25% of travel.

Preferred

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

We hire for skills and capabilities, not just credentials if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Devens - MA - US: $116,680 - $141,388 Madison - Giralda - NJ - US: $109,050 - $132,139 New Brunswick - NJ - US: $109,050 - $132,139 Princeton - NJ - US: $109,050 - $132,139 Seattle - WA: $119,950 - $145,354

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at