Senior Manager, Sterility Assurance

Position Summary

The Sr. Manager, Sterility Assurance is a highly critical role responsible for managing Sterility Assurance which supports the CAR T manufacturing site. Key responsibilities include:

• Supporting final product testing and release, incoming components and materials testing and release.
• Maintaining and developing SOPs, forms, and methods for compliant operation.
• Ensuring compliance with cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations.
• Managing and developing direct reports.
• Onboarding new materials required to support manufacturing operations.
• Supporting manufacturing schedule and needs.
• Ensuring employees are properly trained and qualified to perform assigned tasks.
• Managing and executing the contamination control strategy for the facility.
• Generating, owning, and supporting change controls, deviations, and CAPAs within the eQMS system.
• Supporting equipment, facility, and microbiological method qualifications.
• Ensuring site and department objectives are met.
• Managing and addressing manufacturing issues involving sampling and/or test excursions or questions during shift operations.

Duties/Responsibilities

To 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 support the compliant operation.

Qualifications

• Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of cell therapy products.
• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action and alert limits and data trending.
• Advanced knowledge of Microbiology.
• Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc.
• Advanced verbal and written communication skills.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Team-oriented and cross-departmental working ability.
• Leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
• Advanced mentoring and coaching, influencing, negotiating and personal interaction skills.
• Advanced 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.
• Microbiology laboratory and/or Environmental Monitoring setting experience.
• Experience working with cell therapy products preferred.
• 2-3 years of leadership/managerial experience required.
• 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.

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: Flexible time off (unlimited, with manager approval), 11 paid national holidays, and 3 optional holidays.