Director, Cell Therapy Drug Product Operations Risk Management

Role Summary

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.

Responsibilities

• Assess risks/vulnerabilities which impact our ability to reliably supply product on-time and in-spec to patients, with scope encompassing Suppliers, Process, and Analytical
• 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

• 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.