Associate Director, Cell Therapy Network CQV

Bristol Myers Squibb • Devens, MA

1d • Hybrid

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. The Associate Director, Cell Therapy Network CQV, is responsible for the network strategy for equipment/facility/utility Commissioning, Qualification, and Validation. The scope encompasses the internal CT manufacturing sites and engagement with external CMOs via Virtual Plant Teams. This role will partner cross-functionally with site CQV leads, site equipment owners, Cell Therapy network Digital Plant leaders, the BMS QMS Qualification Global Process Owner, and CTTO Global Equipment Owners.

Requirements

• B.S., M.S., or Ph.D. in Mechanical Engineering, Chemical Engineering, or related scientific/engineering discipline with: 15+ years w/ B.S. or 12 years w/ M.S. or 8 years w/ Ph.D. of experience in biologics or cell therapy GMP manufacturing support.
• Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
• Excellent strategic thinking, problem-solving, decision-making, and communication skills.
• Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks.
• Excellent interpersonal, collaborative, team building, and communication skills.

Nice To Haves

• Ability to effectively utilize project management and Lean Six Sigma tools is a plus.

Responsibilities

• Establish strategy and deliver optimized and harmonized CQV approaches across the Cell Therapy network.
• Work collaboratively with Cell Therapy network Digital Plant and BMS enterprise qualification L2 to synthesize guidance in standards for qualification of equipment with internal computer systems.
• Oversight of Cell Therapy equipment validation execution across network, ensuring lifecycle management of the standardized approach.
• Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied, maintaining all sites in an inspection-ready status.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree