Manager, Sterility Assurance
Bristol Myers Squibb
5 hours ago
On-site
Devens, MA
Operations
Position Summary:
- Oversee and drive continued compliance of the site contamination control program, including facility design/modifications, aseptic process validation, aseptic observer, aseptic gowning and operator qualification, and environmental/clean utility monitoring.
- Collaborate cross-functionally with internal/external stakeholders to drive continuous improvement of site sterility assurance systems and processes.
Duties/Responsibilities:
- Execute/support the contamination control strategy (aseptic processes, facility design/modification, gowning certification/recertification, environmental monitoring, clean utility systems design/modification, EMPQs).
- Ensure sterility assurance activities comply with applicable regulatory requirements (e.g., FDA, EMA, USP) and BMS policies.
- Serve as Sterility Assurance SME for projects, continuous improvement, and Quality Risk Management.
- Generate/own/review/act as SME for document revisions, change controls, deviations, proactive initiatives, CAPAs in eQMS.
- Support metrics and data analysis (EM/CU trends, capacity ramp reports).
- Oversee environmental monitoring, clean utility monitoring, aseptic process simulation, aseptic performance qualification, aseptic observer, and aseptic gowning programs.
- Support equipment/facility/microbiological method validation and qualifications.
- Facilitate Environmental Action Committee governance meetings.
- Author/review filing submissions and updates.
- Perform final review of root cause analysis for EM deviations.
- Ensure site/department objectives are met; support onboarding of new manufacturing materials.
- Act as SME during regulatory inspections and respond to regulatory inquiries.
- Support manufacturing/production issues, questions, and triage meetings; participate in global forums and project teams.
- Occasional on-call during holidays/off shift; occasional travel.
- Routinely gown into manufacturing cleanroom and maintain gowning qualification for aseptic processing areas.
- Perform other tasks as required.
Qualifications (Specific Knowledge, Skills, Abilities):
- Advanced understanding of microbiology and aseptic processing.
- Experience with QC microbiology and environmental/clean utility monitoring procedures, techniques, and laboratory methods.
- EM/CU monitoring experience and/or EM/CU program development.
- Knowledge of facility control systems (e.g., HVAC, utilities, DPs, cleaning/disinfection).
- Knowledge of US and EU cGMP regulations and guidance.
- Apply quality risk management principles per ICH Q9 to contamination control systems.
- Proficient with quality management systems (SOPs, Change Control, Deviations, CAPAs).
- Strong problem solving, troubleshooting, investigation, and decision-making under pressure.
- Team-oriented; able to work independently and collaborate cross-functionally.
- Flexible/adaptable; able to meet timelines under pressure.
- Internal and regulatory inspection experience preferred.
- Advanced technical writing and verbal/written communication.
- Cell therapy manufacturing knowledge highly desirable.
Education/Experience:
- Bachelor’s degree in STEM preferred (high school diploma/Associates with equivalent education/experience may be considered).
- Minimum 6 years in a cGMP-governed environment; preferably 3+ years in QC Microbiology and/or sterility assurance.
Benefits (explicitly stated):
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing programs (BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial protection (401(k), disability, life and accident insurance, supplemental insurance, travel protection, liability, identity theft benefit, legal support, survivor support).
- Paid Time Off: flexible time off (unlimited, manager approval) and paid national holidays; 160 hours annual paid vacation for certain locations/employment types; plus additional eligibility for sick time, volunteer days, summer hours (eligibility-based), leaves of absence, and annual Global Shutdown between Christmas and New Year’s Day.
Location/Compensation (explicitly stated):
- Devens, MA: US $100,480–$121,756 (full-time FTE). Additional incentive cash/stock may be available (based on eligibility).
Application instructions:
- No additional application instructions provided beyond the job posting.
- Oversee and drive continued compliance of the site contamination control program, including facility design/modifications, aseptic process validation, aseptic observer, aseptic gowning and operator qualification, and environmental/clean utility monitoring.
- Collaborate cross-functionally with internal/external stakeholders to drive continuous improvement of site sterility assurance systems and processes.
Duties/Responsibilities:
- Execute/support the contamination control strategy (aseptic processes, facility design/modification, gowning certification/recertification, environmental monitoring, clean utility systems design/modification, EMPQs).
- Ensure sterility assurance activities comply with applicable regulatory requirements (e.g., FDA, EMA, USP) and BMS policies.
- Serve as Sterility Assurance SME for projects, continuous improvement, and Quality Risk Management.
- Generate/own/review/act as SME for document revisions, change controls, deviations, proactive initiatives, CAPAs in eQMS.
- Support metrics and data analysis (EM/CU trends, capacity ramp reports).
- Oversee environmental monitoring, clean utility monitoring, aseptic process simulation, aseptic performance qualification, aseptic observer, and aseptic gowning programs.
- Support equipment/facility/microbiological method validation and qualifications.
- Facilitate Environmental Action Committee governance meetings.
- Author/review filing submissions and updates.
- Perform final review of root cause analysis for EM deviations.
- Ensure site/department objectives are met; support onboarding of new manufacturing materials.
- Act as SME during regulatory inspections and respond to regulatory inquiries.
- Support manufacturing/production issues, questions, and triage meetings; participate in global forums and project teams.
- Occasional on-call during holidays/off shift; occasional travel.
- Routinely gown into manufacturing cleanroom and maintain gowning qualification for aseptic processing areas.
- Perform other tasks as required.
Qualifications (Specific Knowledge, Skills, Abilities):
- Advanced understanding of microbiology and aseptic processing.
- Experience with QC microbiology and environmental/clean utility monitoring procedures, techniques, and laboratory methods.
- EM/CU monitoring experience and/or EM/CU program development.
- Knowledge of facility control systems (e.g., HVAC, utilities, DPs, cleaning/disinfection).
- Knowledge of US and EU cGMP regulations and guidance.
- Apply quality risk management principles per ICH Q9 to contamination control systems.
- Proficient with quality management systems (SOPs, Change Control, Deviations, CAPAs).
- Strong problem solving, troubleshooting, investigation, and decision-making under pressure.
- Team-oriented; able to work independently and collaborate cross-functionally.
- Flexible/adaptable; able to meet timelines under pressure.
- Internal and regulatory inspection experience preferred.
- Advanced technical writing and verbal/written communication.
- Cell therapy manufacturing knowledge highly desirable.
Education/Experience:
- Bachelor’s degree in STEM preferred (high school diploma/Associates with equivalent education/experience may be considered).
- Minimum 6 years in a cGMP-governed environment; preferably 3+ years in QC Microbiology and/or sterility assurance.
Benefits (explicitly stated):
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing programs (BMS Well-Being Account, BMS Living Life Better, EAP).
- Financial protection (401(k), disability, life and accident insurance, supplemental insurance, travel protection, liability, identity theft benefit, legal support, survivor support).
- Paid Time Off: flexible time off (unlimited, manager approval) and paid national holidays; 160 hours annual paid vacation for certain locations/employment types; plus additional eligibility for sick time, volunteer days, summer hours (eligibility-based), leaves of absence, and annual Global Shutdown between Christmas and New Year’s Day.
Location/Compensation (explicitly stated):
- Devens, MA: US $100,480–$121,756 (full-time FTE). Additional incentive cash/stock may be available (based on eligibility).
Application instructions:
- No additional application instructions provided beyond the job posting.