Bristol Myers Squibb is a pharmaceutical company that offers a wide variety of competitive benefits, services and programs to its employees. The company is looking for a Senior Manager, Sterility Assurance to manage Sterility Assurance which provides support to the CAR T manufacturing site.
Requirements
- 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
- Must be team-oriented and has the demonstrated ability to work crossdepartmentally throughout the manufacturing site
- Demonstrated 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
- Demonstrated resource management and planning skills
- Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines
- 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 working with cell therapy products is 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
- Medical
- pharmacy
- dental and vision care
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
- Financial well-being resources and a 401(K)
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility
- Parental, caregiver, bereavement, and military leave
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
- Other perks like tuition reimbursement and a recognition program
