Senior Manager, Sterility Assurance

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.The Sr. Manager, Sterility Assurance QC Microbiology, is a highly critical role and is responsible for managing the QC Sterility Assurance initiatives, which support the CAR T manufacturing site.This department is responsible for microbiological support-related testing of in-process samples, final product testing, critical utilities sampling and testing, Validation and requalification support, incoming component testing, and microbiological identification. Sampling and testing must meet or exceed FDA, MHRA, PMDA, EU, and other governmental regulations or guidelines. The Sr. Manager, Sterility Assurance QC Microbiology, is responsible for acting as the SME during regulatory inspections.Responsibilities:Serve as a sterility assurance subject matter expertOwn and manage CAPAs, Change Controls and other quality records utilizing the site QRM system.Regular communication to senior levels of management Collaborate with peers in the cell therapy network to align practicesLead collaboration events with process experts, and quality teamsPerform analysis of microbiological data and prepare recommendationsAuthor study reportsManage sterility assurance projectsRequired Skills/Knowledge:Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to the manufacturing of cell therapy products.Advanced data integrity knowledge and practices.Intermediate understanding of statistics, control charts, action, and alert limits.Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etcExperience of new equipment qualification activities: URS, IQ, OQ, PQ, PVs, etc.Understanding of environmental monitoring program, Aseptic gowning, tools and techniques.Advanced verbal and written communication skillsDemonstrated critical reasoning, problem-solving, troubleshooting, investigation, and decision-making skillsMust be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing siteDemonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environmentAdvanced mentoring and coaching, influencing, negotiating, and personal interaction skillsDemonstrated resource management and planning skillsMust be flexible and adaptable, and able to work under pressure, while meeting designated timelinesAdvanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.Advanced knowledge of Microsoft Word, Outlook, Excel, PowerPoint, etc.Requirements:Bachelor’s degreeExperience in performing and leading Risk Assessments7 years of Quality Microbiology work experience in a cGMPAt least 2 years of leadership/managerial experience(An equivalent combination of education of experience may substitute)Preferred Requirements:Bachelor’s degree in microbiologyExperience working with cell therapy productsExperience in participating and supporting regulatory audits preferred: FDA,MHRA, PMDA, etc.Experience in supporting sterile compounding and filling operations.Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.#LI-Onsite#BMSCART#VETERANSIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.