Manager, QC Sample Management

Working with Us Challenging. 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 Purpose and Scope of Position: The Manager, QC Sample and Material Management is a people leader responsible for the management of samples and materials used in the analytical and microbiology laboratories at the CAR T manufacturing facility in Summit, NJ (Building S12). This includes responsible for management and inventory of all Quality Control samples received from Manufacturing and customers. Includes bulk material inventory management, management of QC retain samples, assay controls and critical reagent support as needed. This role actively prepares for and participates in regulatory inspections. Required Competencies: General knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products. • Effective verbal and written communication skills with the ability to tailor style for a wide variety of audiences. • Ability to collaborate cross functionally to drive operational and quality excellence. • Proven organizational and time management skills. • Demonstrated strategic and critical reasoning, problem solving, troubleshooting, and decisionmaking skills. • Possesses and drives growth mindset. • Ability to coach, influence, and negotiate. • Proven ability to effectively work independently, delegate and collaborate. • Self-motivated, driven and focused on team building and talent development • Proficiency using Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments. • Ability to interpret and author general, technical, and complex business documents. • Proven knowledge and implementation of data integrity principles. • Ability to represent the department in regulatory inspections. • Requires strong sense of urgency, responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance. • Proficiency in laboratory information management systems (LIMS), MS Office applications and scheduling programs Education and Experience Bachelor’s degree required Advanced Degree Preferred Fluent in speaking/writing in English. 3 years of relevant work experience required. 1 years of leadership experience with direct reports required. Duties and Responsibilities: Oversees all team activities related to: • Sample management functions (receipt, dispensing, and retains program) • Stability sample management • Bulk material management (move orders, Kanban) • Assay control inventory • Quality records (deviations, CAPA, Change Control,) within the team • Critical reagents management (as needed) Manages and develops direct reports including: • Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs. • Ensures employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports. Performs other tasks as required Working Conditions: The incumbent will be required to work in office and laboratory environments. • The incumbent will be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis. • The incumbent (or their designee) will be expected to be on call to support manufacturing and/or test excursions events/questions involving sampling and/or materials during shift operations. • Occasional travel may be required. 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. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. If 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 Careers With 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 Protocol Physical 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. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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