Scientist, Sterility Assurance

Bristol Myers Squibb • Summit, NJ

1d

About The Position

The Scientist, Sterility Assurance, provides support to the CAR T manufacturing site. This role supports facility design/modifications, the aseptic process validation program, operator qualification, gowning certification, critical utilities, final product testing and adherence to the contamination control program for the site. The Scientist, Sterility Assurance is responsible to act as the SME during regulatory inspections. 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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience working with cell therapy products are preferred.
• Experience working with cell therapy products is preferred.

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.

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.
• Work-life benefits include: 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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees