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Director, Cell Therapy Drug Product Operations Risk Management

Lead risk assessments to ensure reliable supply of cell therapy products
Devens, Massachusetts, United States
Senior
yesterday
Massachusetts Staffing

Massachusetts Staffing

Massachusetts Staffing is not a company; mass.gov is the official website for the Commonwealth of Massachusetts, providing government-related information and services.

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Director, Cell Therapy Drug Product Operations Risk Management

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.

The Director, Cell Therapy Drug Product Operations Risk Management, is responsible for delivering improvements in commercial cell therapy product supply reliability by leading risk assessments, prioritizing risk mitigations, and managing the resulting project portfolio. The scope encompasses suppliers, process, and analytics across the DPO manufacturing network. As a key member of the Proactive Risk Management team, this role will partner cross-functionally with Cell Therapy Technical Operations, Analytical Science & Technology, Quality, Regulatory-CMC, Supply Chain, and Product Strategy to holistically assess and mitigate risks to supply reliability.

Key Responsibilities:

  • Assess risks/vulnerabilities that impact our ability to reliably supply product on-time and in-spec to patients, with scope encompassing suppliers, process, and analytics.
  • Create a holistic Risk Register capturing the landscape of risks and mitigation projects, ensuring alignment with Business Continuity Management and Quality Risk Management.
  • Prioritize a selection of risk mitigation projects and identify opportunities to accelerate.
  • Partner with matrix team leads to build project schedules, charters, budgets, and resourcing plans.
  • Identify areas for deeper dive risk assessment and systems/processes which are targets for improvement; develop plans to address.
  • Foster a culture of accountability, inclusion, integrity, and innovation.

Qualifications & Experience:

B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, or related discipline with:

  • 15+ years (B.S./M.S.) or 12+ years (Ph.D.) of experience in biologics or cell therapy process development, analytical development, tech transfer, and/or 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.
  • Ability to effectively utilize project management and Lean Six Sigma tools is a plus.
  • Excellent interpersonal, collaborative, team building, and communication skills.
  • Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues.
  • Approximately 10-20% travel.
  • BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.

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Director, Cell Therapy Drug Product Operations Risk Management
Devens, Massachusetts, United States
Operations
About Massachusetts Staffing
Massachusetts Staffing is not a company; mass.gov is the official website for the Commonwealth of Massachusetts, providing government-related information and services.