Bristol Myers Squibb · 1 day ago
Scientist, Sterility Assurance
Summit West - NJ - US
Full-time
Onsite
Mid Level
$84K/yr - $102K/yr
3+ years expBristol Myers Squibb is a company that focuses on transforming patients' lives through science. The Scientist, Sterility Assurance role involves supporting the CAR T manufacturing site, including aseptic process validation, final product testing, and acting as a subject matter expert during regulatory inspections.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Support final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems
Development and management of SOPs, forms, and methods required to ensure GMP compliance
Ensures the execution and support of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning certification/recertification program critical utilities, and EMPQs
Serves as Sterility Assurance SME for projects, continuous improvement initiatives as well as the Quality Risk Management Program
Generates, owns, and/or supports change controls, deviations, proactive initiatives, CAPAs etc. within the eQMS system
Supports metrics and data analysis, including generation of Environmental Monitoring trend and regulatory ramp reports
Support equipment, facility, and microbiological method qualifications
Ensure the site and department objectives are met
Support the manufacturing schedule and needs. The incumbent will be required to gown into the Aseptic core and supporting areas, on an as-needed basis
The Scientist incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations
Acts as an SME during regulatory inspections and responds to all regulatory inquiries in a timely manner
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job
Occasional travel may be required
Perform other tasks as assigned
Qualification
Required
Intermediate knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of cell therapy products
Data integrity knowledge and practices
Intermediate understanding of statistics, control charts, action and alert limits
Intermediate knowledge of Microbiology
Ability to lead and maintain data and trending
Advanced verbal and written communication skills
Demonstrate critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills
Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site
Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines
Knowledge of safety, OSHA, and EPA regulations. Electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc
Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc
Bachelor's degree required, preferably in Microbiology or related science
3 years relevant work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring
Preferred
Experience working with cell therapy products are preferred
Experience working with cell therapy products is preferred
Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc
Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments
An equivalent combination of education of experience may substitute
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
Based on eligibility*, additional time off for employees may include 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
Represents job field similar to this job
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
Pharmaceutical Technology
2026-01-22
Company data provided by crunchbase