Associate Director, Aseptic Operational Support

Bristol-Myers Squibb Company; New Brunswick (NJ); Presencial; USD 162.000 - 196.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical insurance

Retirement plan

Paid holidays

Flexible time off

Resumo da vaga

Bristol Myers Squibb is seeking an Associate Director, Aseptic Operational Support with expansive expertise in aseptic processing and contamination control to guide facility and utility design, qualification, and regulatory readiness. This role focuses on integrating CCS requirements into design and ensuring sterilization and WFI systems meet stringent standards.

The position requires 10+ years in sterility assurance, with at least 4 years in leadership, and involves collaboration with MS&T,

Qualificações

• Required: BS in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• 10+ years in sterility assurance, aseptic manufacturing or pharmaceutical quality; at least 4 years in a leadership/enterprise role.
• Strong experience defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).

Responsabilidades

• Review and approve global risk assessments and quality impact assessments for facilities and utilities.
• Serve as Global Quality SME for aseptic facility/utility design and issue design packages, URS, DQ, change controls.
• Own sterilization standards and SUT knowledge; ensure regulatory alignment and design for CCS, WFI, PW, sterilization validation.

Conhecimentos

Aseptic processing

Contamination control

Risk assessment

Regulatory inspections

Quality by Design

Cross-functional collaboration

Formação

BS in Microbiology

Descrição da vaga

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.

*** 2 year term based in Indianapolis***

Based in NJ or MA after the 2 years

The Associate Director provides authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments, partnering closely with MS&T on technology transfer and process design activities, and with Engineering on capital project execution. The role does not own facility construction or engineering delivery but serves as the MQSA voice ensuring sterility assurance and microbial control requirements are built into the facility. At RayzeBio and BMS internal manufacturing sites, as well as providing authoritative technical oversight and strategic direction across facility, utility, equipment, and process domains.

Key Responsibilities

• Risk Assessment & Quality Impact Governance
  Review and approve global risk assessments and quality impact assessments (QIAs) associated with contamination events and microbial control failures around Facilities & Utilities.
  Lead and author high-complexity Business Technical Assessments (BTAs) to support regulatory submissions, systemic issue resolution, and cross-site technical alignment when associated with Facilities & Utilities
  Develop and maintain comprehensive investigation and inspection-readiness materials for systemic aseptic and microbial control issues, serving as a subject matter expert on BMS Facilities & Utilities during regulatory inspections (FDA, EMA, and other health authorities)
• Aseptic & Microbial Control by Design
  Serve as the Global Quality SME for aseptic facility and utility design, providing expert review and approval of design packages, User Requirement Specifications (URS), design qualification (DQ) protocols, and change controls associated with cleanrooms, barrier systems (RABS/isolators), and critical utilities.
  Define and maintain enterprise-level Quality standards and requirements for aseptic facility and utility design, including cleanroom classification, airflow and pressure differential design, surface finish specifications, and drainability — ensuring alignment with EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance, and ISO 14644 series.
  Provide by-design oversight for facility, utility and equipment changes — both sterile and non-sterile — ensuring microbial and particulate contamination risks are systematically identified, assessed, and controlled at the design stage
  Serve as the technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, integrating contamination control strategy (CCS) requirements into design specifications
  Provide Quality oversight for critical utility systems — including Water for Injection (WFI), Purified Water (PW), clean steam, clean compressed gases, and HVAC/clean air systems — covering design, qualification, and ongoing microbial and chemical control requirements.
  Partner with Engineering and Validation teams to ensure facility and utility qualification (IQ/OQ/PQ) programs adequately demonstrate microbiological and contamination control performance against defined acceptance criteria.
  Champion Quality by Design (QbD) and risk-based thinking across all phases of facility and equipment lifecycle management
  Provide oversight of aseptic facility and utility design standards at ExM partners (CMOs/CDMOs), reviewing facility design packages, CCS documentation, and utility qualification strategies as part of site qualification and ongoing oversight programs, as required.
  Support quality risk assessments of ExM facility and utility design, identifying gaps relative to BMS standards and current regulatory expectations, and driving remediation through the ExM quality governance framework
• Sterilization Standards & Single-Use Technology (SUT)
  Own the development and governance of enterprise design standards for sterilization technologies, with expertise in single-use technology (SUT) and consumable qualification
  Define sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways, supporting both MS&T and Engineering in design decisions
  Ensure sterilization design standards remain current with evolving regulatory guidance (e.g., ISO 11135, ISO 11137, ISO 11040) and industry best practices

Qualifications & Experience

• Education
  Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• Experience
  10+ years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality — with at least 4 years in a leadership or enterprise-level role.
  Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment within a regulated pharmaceutical or biologics manufacturing environment.
  Demonstrated experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).
  Proven track record in designing or overhauling APS/media fill programs or CCS frameworks at a network or enterprise scale.
  Hands‑on experience with sterilization validation and single‑use system qualification.
• Skills & Competencies
  Expert‑level knowledge of aseptic processing regulations and guidance: FDA Aseptic Processing Guidance (2004/Revised), EU GMP Annex 1 (2022), USP , ISO 13408 series, PDA Technical Reports (TR22, TR13, TR70, TR90).
  Strong command of contamination control strategy (CCS) development as required under EU GMP Annex 1.
  Proficiency in risk assessment methodologies: FMEA, HACCP, fault tree analysis, risk ranking and filtering.
  Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques.
  Experience with sterilization technologies: EtO, gamma, steam (moist heat), dry heat, and VHP/HPV.
  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

Compensation Overview

• Devens - MA - US: $173,280 - $209,976
• Indianapolis - RayzeBio - IN: $161,950 - $196,246
• Madison - Giralda - NJ - US: $161,950 - $196,246
• New Brunswick - NJ - US: $161,950 - $196,246
• Princeton - NJ - US: $161,950 - $196,246

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 https://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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607605 : Associate Director, Aseptic Operational Support