Manager, Quality Control Sample Management in Devens, MA

Bristol Myers Squibb • Devens, MA

55d • Onsite

About The Position

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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. Bristol Myers Squibb is seeking a Manager, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Sample Management shift, responsible for the management of QC samples and materials in support of the QC laboratories. This includes, but is not limited to, mentoring, training and managing the QC Sample Management team, maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and continuously improving processes, reviewing and approving documents, and overseeing sample tracking, delivery, and destruction. This role works from 6AM to 6PM following a 12-hour rotating shift (36/48 hours over a 2-week period) which includes working every other weekend, holidays falling on scheduled workdays, and during adverse weather conditions in support of QC and the manufacturing facility. Flexibility to work irregular hours and short notice overtime may be required.

Requirements

• Bachelor's degree required, preferably in Chemistry, Microbiology or related science.
• 6+ years of relevant work experience, preferable in a regulated environment.
• 2+ years of management and people leader experience.
• An equivalent combination of education and experience may substitute.
• The incumbent will be working around biohazardous materials.
• The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
• Experience with cold chain sample storage and transfer in a GMP regulated environment.
• Familiar with Excel, Visio, Power Point, and other software systems.
• Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
• Ability to mentor associates, manage multiple assignment while meeting timelines in a GMP environment.
• Advanced ability to work in a collaborative team environment and train others.
• Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Excellent organizational and critical thinking skills.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

Nice To Haves

• Experience with laboratory LIMS and ERP systems (e.g., SAP) preferred.

Responsibilities

• Provide supervision of QC Sample Management shift and oversee the daily Sample Management activities related to in-process, final release and stability testing of cell therapy drug product.
• Develop and manage a daily work plan for QC associates. Report out quality and operational metrics.
• Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.
• Hire, mentor and develop the team members to support the business operations and employee career development.
• Oversee the training of the team members.
• Review and approve procedures for Sample Management activities.
• Collaborate with other departments to identify and implement process improvements.
• Own and evaluate relevant change controls, investigations, deviations, CAPAs.
• Apply critical thinking skills when working on new procedures or process improvements.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Perform other tasks as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees