Bristol Myers Squibb · 2 days ago
Quality Control Environment Monitoring Supervisor
Indianapolis, IN
Full-time
Onsite
Senior Level
$108K/yr - $131K/yr
5+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival of people with cancer. The Quality Control Environment Monitoring Supervisor will oversee the environmental monitoring program supporting GMP manufacturing operations related to radiopharmaceuticals, ensuring compliance with regulations and quality standards.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Manage EM program
Supervise EM technicians /analysts performing viable, non-viable, personnel, settling plates monitoring in ISO- classified and controlled spaces
Schedule routine and non-routine EM activities to support manufacturing operations and facility readiness
Oversee execution of environmental and utility sampling including microbial identification workflows
Ensure laboratory activities follow SOPs, aseptic techniques, gowning procedures and safety requirements
Review and/or approve EM data, escalate excursions
Lead or support investigations for EM -related investigations, including root cause analysis and CAPA development to ensure timely close-out
Ensure EM program documentation such as SOPs, forms, maps are current and audit-ready
Ensure EM trending, monthly/quarterly reports are performed in a timely manner
Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, validation/verifications and equipment qualifications
Develop and maintain appropriate documentation, particularly data analysis and team KPI's
Supervise a team of EM technicians /analysts
Assign tasks and prioritize workload to ensure timely completion of in an on-time and right first time manner
Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the site
Coach team members, conduct performance evaluations and support career development
Support continuous improvement programs for EM such as new EM technologies and improve data visibility
Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratories
Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed
Work with Manager and/or Investigation Writer to ensure any discrepancies are resolved in a timely manner
Assist in the routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness
Work with Quality Assurance and Management to implement internal audits
Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits
Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as needed)
Qualification
Required
BS in microbiology or related field with 5+ years of direct radiopharmaceutical experience or 5+ years of experience in pharmaceutical field, OR MS in microbiology or related field with 5+ years of experience in pharmaceutical field
At least a year of supervisory experience
A strong background in microbiology and aseptic manufacturing is required
Highly motivated and organized professional with the ability to work independently or in a team environment
Proficient in viable and non-viable monitoring techniques
Strong understanding of cleanroom classifications
Attention to details and data integrity
Experience with software such as Sherpa or LIMs or equivalent data systems
Multi-disciplined scientist with GMP experience
Very personable with strong communication skills and cross-functional collaboration
Ability to multi-task and prioritize work based on multiple workflows
Good organizational skills are required
Work with multiple computer systems, including Microsoft Office
Excellent professional ethics, integrity, and ability to maintain confidential information
Preferred
Experience in radiopharmaceutical field
Experience handling radioactive materials
Radiochemistry experience preferred
Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
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