QC Analytical Manager, Molecular, Cell Therapy in Devens, MA

Bristol Myers SquibbDevens, MA
29dOnsite

About The Position

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. 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. 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 Analytical, Molecular at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Analytical shift, responsible for QC bioanalytical testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug product. The Manager, QC Analytical will also be responsible for hiring, mentoring and developing the QC Analytical team to support business operations and employee career development.

Requirements

  • Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment.
  • Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
  • Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.
  • Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Excellent organizational and critical thinking skills.
  • Advanced problem-solving ability/mentality, technically adept and logical.
  • Advanced ability to communicate effectively with peers, department management, and cross functional peers.
  • Proficient with Excel, Visio, PowerPoint, and other common software applications.
  • The incumbent will be working around biohazardous materials.
  • Bachelor's degree required, preferably in Chemistry, Microbiology or related science.
  • 6+ years of relevant laboratory work experience, preferably in a regulated environment.
  • 2+ years of management and people leader experience.
  • An equivalent combination of education and experience may substitute.

Nice To Haves

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

Responsibilities

  • Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product.
  • Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved.
  • Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities.
  • Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements.
  • Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.
  • Own and evaluate relevant change controls, investigations, deviations, CAPAs.
  • Hire, mentor, and develop team members to support the business operations and employee career development.
  • Oversee training of the team members.
  • Communicate effectively with management regarding task completion, roadblocks, and needs.
  • Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings.
  • 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.

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What This Job Offers

Job Type

Full-time

Career Level

Manager

Industry

Chemical Manufacturing

Number of Employees

5,001-10,000 employees

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