Senior Manager, Quality Control Sample Management and Planning Cell Therapy

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Summary:

Bristol Myers Squibb is seeking a Senior Manager, QC Sample Management and Planning at the Cell Therapy Facility (CTF) in Devens, MA. The Senior Manager will lead a team of managers and individual contributors, responsible for QC Sample and Material Management and QC Operation Planning. The Senior Manager will be responsible for hiring, building out, mentoring and developing the team, establishing and continuously enhancing effective collaboration and communication with cross functional departments such as Manufacturing, Supply Chain, Integrated Facility Management, QC and QA Operations. The responsibilities of the team includes but are not limited to: maintaining and tracking testing samples, backups, characterization samples, stability sample, and retains etc., overseeing the inventory of laboratory chemicals, critical reagent supplies, scheduling analytical and microbiology lab testing, creating and continuously improving processes, reviewing and approving documents, and managing deviations and investigations. This position is a first shift position, however, it may require occasional support to operations on weekends or holidays when necessary within a 40-hour work week.  The Senior Manager role is stationed in Devens, MA and reports to the Associate Director of QC Systems.

Job Responsibilities:

Leadership and management responsibilities:

• Hire, mentor and develop the team members to support the business operations and employee career development
• Represent QC Sample Management team, establish the collaborative working relationship with cross functional group to support clinical and commercial manufacturing, testing and sample management
• Establish the efficient and effective working shift structure to support business operations with Lean lab operation principle
• Develop KPI for QC Department performance metrics, maintain high team performance and continuous improvements
• Lead the team to develop, deploy and maintain required training
• Performing approvals for relevant sample management activities

Core function area responsibilities:

• Create, revise and review operational processes, technical documents, such as SOPs and working instructions for sample and critical reagent management
• Managing QC samples, QC reagents, chemical, consumables, assay controls, and critical materials including chain of custody, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.
• Work closely with QC Analytical and Microbiology Lab Operations, develop and manage QC testing schedule based on sample receipt, testing turn around, batching testing for equipment and operational efficiency
• Support QC management for mid and long term resource planning
• Owning and evaluating relevant change controls, investigations, deviations, CAPAs
• Implement 5S, Lean Lab Operations and FIFO principles as appropriate
• Apply critical thinking skills when working on new procedures or process improvements
• Communicate effectively with management regarding task completion, roadblocks, and needs

Qualifications and Education Requirements:

• Advanced experience with sample and material management in pharmaceutical/Biotech GMP environment
• Experience in six sigma lean lab operation principles
• Experience in the use of LIMS preferably LabWare LIMS, familiar with Excel, Visio, Power Point, and other software systems.
• Excellent organizational and critical thinking skills, problem solving and decision-making abilities
• Ability to work independently and collaboratively with cross-functional local and global teams in a high-paced environment, meet deadlines, and prioritize work from multiple projects
• Strong written and verbal communications skills and interpersonal skills; Advanced ability to communicate effectively and concisely with peers, department management and cross-functional peers
• Ability to mentor and train team members
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

• Bachelor’s degree required, preferably in Chemistry, Microbiology or related science field.
• 10+ years of relevant work experience, preferable in a regulated environment.
• 4+ years of management and people leader experience.
• An equivalent combination of education and experience may substitute.

Working Conditions:

• The incumbent will work 40-hours per week. Support manufacturing operations that may include shift coverage consisting of on call, shift, and/or weekend coverage.
• The incumbent may include working around biohazardous materials.
• The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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