Executive Director, Cell Therapy Process and Analytical Development

Essential Functions

• Demonstrate rigorous scientific discipline to translate R&D activities into CMC-compliant development strategies supporting early- and late-phase clinical programs
• Own and drive the strategic planning and scientific strategy for Process and Analytical Development across cell therapy programs, including resource prioritization, governance of key technical decisions, and proactive risk assessment and mitigation to deliver program and platform outcomes
• Lead and manage Process and Analytical Development laboratories through senior people leaders across a multi-layered organization, including organizational design, talent development, succession planning, and building scalable capabilities to meet current and future portfolio needs
• Develop and execute phase-appropriate experimental strategies aligned with FDA CMC expectations for cell therapies (ATMPs a plus)
• Partner cross-functionally with Manufacturing, MS&T, Quality, Regulatory, Operations, Supply Chain, Finance and Human Resources to ensure aligned execution at the site level, including negotiating priorities, timelines, scope, and resourcing across stakeholders and escalating trade-offs as needed.
• Actively participate as a member of the site leadership team and ensure a high level of teamwork and partnership across functions
• As a key liaison between the NC-CPC laboratories with RACTHERA/S-RACMO, Development R&D, and Marlborough cell therapy lab to support cross-functional experimental work, facilitate knowledge transfer, and align scientific development approaches across programs and sites
• Partner with key cross-functional stakeholders and subject matter experts to communicate updates on functional assay development and performance, while driving continuous improvement of both analytical methods and process development approaches, including the design and execution of cell therapy characterization studies aligned with evolving program and regulatory expectations
• Lead technical strategy and execution for regulatory submissions and clinical trial support, including data interpretation and ongoing risk assessment, risk mitigation planning, and issue escalation to enable compliant, timely delivery
• Participate in regulatory interactions, including FDA meetings and inspections where applicable
• Shape and drive key Cell Therapy development and long-term platform strategy, translating enterprise and site objectives into actionable strategic plans, prioritized roadmaps, and measurable outcomes, with accountability for continuous improvement

Knowledge, Skills and Abilities

• Deep expertise in cell therapy process development and analytical development
• Strong understanding of FDA CMC requirements for cell therapies
• In depth experience in leading complex root cause analysis
• Integrate Lean Six Sigma approaches to processes
• Highly collaborative leadership style with proven ability to work cross-functionally
• Strategic mindset with the ability to balance scientific depth and operational execution
• Strong critical thinking and problem-solving skills; ability to approach challenges creatively
• Coach skills to develop team
• High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture

Education & Experience Requirements

• Ph.D. in Cell Biology, Molecular Biology, Biochemistry, or a related scientific discipline
• 15+ years of direct industry experience in pharma/biotech, specifically in cell therapy or ATMP process and analytical development
• Demanded experience supporting regulatory submissions
• Experience executing early- and/or late-phase clinical trials
• Proven experience leading teams and managing scientific organizations
• Experience managing process and analytical development laboratories and associated teams
• Experience participating in FDA regulatory meetings

Preferred Experience

• Commercial-stage development experience
• Experience with stem cell or iPSC-based therapies or other ATMP modalities
• Experience supporting or participating in FDA inspections
• Experience working with global health authorities, such as EMA or PMDA