Key Responsibilities
Investigation Impact Assessment – Internal Sites

• Support complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring (EM) excursions, sterility test failures, and process-related contamination events

• Serve as the MQSA SME providing microbiological and aseptic process impact assessments for investigations.

• Apply advanced microbiology, contamination control, and aseptic processing knowledge to critically evaluate root cause analyses (RCA) and assess product, process, and patient impact.

• Review and provide formal sign-off on impact assessment sections of investigation reports, CAPA records, and deviation documentation, ensuring conclusions are scientifically sound and aligned with regulatory expectations (FDA, EMA, ICH).

• Partner with site Investigation Leads to ensure investigation scope, RCA depth, and CAPA effectiveness adequately address microbiological and aseptic process risk.

• Rapid Response & Triage: Lead immediate containment and triage efforts for sterility breaches, including leaks, mold recoveries, and contamination events across a broad network of stakeholders.

• Track and trend impact assessment outcomes across sites to identify systemic issues and emerging risk patterns requiring escalation.

• Support preparation for regulatory agency inspections and audits related to impact assessment findings and sterility assurance.

External Manufacturing (ExM) Support

• Serve as MQSA technical liaison for ExM partners on sterility and microbiological investigations, providing SME guidance to ensure investigation quality aligns with BMS standards. Partner with site the MS&T Virtual plant teams (VPTs) lead to ensure investigation scope, RCA depth, and CAPA effectiveness adequately address microbiological and aseptic process risk.

• Critically review impact assessments and investigation reports submitted by ExM partners, providing constructive feedback to drive adequate risk evaluation and CAPA responses.

• Support quality risk assessments at CMOs, including periodic risk reviews of aseptic processing operations, contamination control programs, and microbiological data trends.

• Design and implement standardized CMO oversight tools, dashboards, and decision trees for aseptic and microbial control performance

• Participate in remote and on-site technical reviews with contract manufacturing organizations (CMOs) as needed during escalated events or regulatory commitments.

• Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions.  Technical SME on Quality Audit team for External manufacturing sites.

Aseptic Process Support

• Provide technical expertise in aseptic processing principles, including barrier technology (RABS/isolators), cleanroom design, gowning programs, and aseptic technique qualification.

• Support aseptic process simulations (media fills) – planning, review, and failure investigation – and provide technical input on process validation and revalidation activities.

• Contribute to contamination control strategies (CCS) development and maintenance per Annex 1 (2022) requirements across internal and ExM sites.

• Assess and advise on aseptic process change controls, providing risk-based SME review of proposed changes to aseptic processing operations, equipment, and environments.

• Support implementation of current Good Manufacturing Practice (cGMP) improvements and regulatory guidance interpretation related to aseptic processing and sterility assurance.

• Interface with the Biologics Drug substance /Drug Product MS&T and/or Cell Therapy Tech Ops group and product specific technical teams to consult on microbial sampling during technology transfers and qualification activities.

  • Technical input, authoring (when applicable), and approval of CMC documents for process validation P.3.5 sections.

  • Support CMC queries and resolution with Global Health Authorities, and support plant inspections.

Technical Leadership & Knowledge Sharing

• Act as a technical resource and mentor for site-level microbiologists and quality professionals, elevating investigation and aseptic process competency across the network.

• Contribute to the development and maintenance of global MQSA standards, SOPs, guidance documents, and training materials.

• Monitor evolving industry trends, regulatory updates, and scientific literature to ensure BMS practices remain current and ahead of compliance risk.

• Represent MQSA in cross-functional teams, steering committees, and governance forums related to sterility and microbiology

• Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing.

Qualifications & Experience

Education

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

Experience 

• Minimum 8 years of direct experience in microbiology, sterility assurance, or aseptic manufacturing within a GMP-regulated pharmaceutical or biopharmaceutical environment

• Deep expertise in aseptic processing operations, environmental monitoring programs, and sterility test methodologies: experience i either biologics and/or cell therapy, or gene therapy.

• Demonstrated experience leading complex microbiological investigations, RCA methods, and CAPA development.

• Strong technical writing skills with experience authoring regulatory-grade investigation reports and deviation records.

• Working knowledge of applicable regulatory frameworks including FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, ICH Q9/Q10, and USP chapters (e.g., <71>, <1116>).

• Ability to work effectively in a matrix organization, collaborating across functions and geographies without direct authority.

• Experience supporting or overseeing External Manufacturing partners from a microbiology and sterility assurance perspective.

• Familiarity with contamination control strategy (CCS) development aligned with EU GMP Annex 1 (2022 revision).

• Experience with isolator and/or RABS barrier technology in aseptic manufacturing.

• Participation in regulatory agency inspections (FDA, MHRA, EMA) as a SME or technical reviewer.

Skills & Competencies 

• Enterprise thinking: Ability to translate site-level data into network-wide strategy and risk management decisions 

• Technical depth: Recognized internal and external authority in aseptic sciences, contamination control, and environmental monitoring 

• Executive communication: Skilled at distilling complex technical content for senior leadership, regulatory agencies, and external partners 

• Change leadership: Ability to influence without direct authority across a complex, matrixed global organization 

• Data fluency: Proficiency in leveraging performance dashboards, trend analytics, and KPIs to drive decisions 

• Collaboration: Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain 

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.

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 athttps://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at