Executive Director, Cell Therapy Process and Analytical Development

Sumitomo Pharma • Morrisville, NC

5d • Onsite

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. This position reports to the SVP, Head of Cell Therapy and is part of the Cell Therapy team within the Technology and Quality organization which leads the development and manufacturing of Regenerative medicine portfolio within SMPA. The role is responsible for leading and providing strategic alignment and direction within SMPA Process and Analytical Development Cell Therapy group, and works closely with CPC based team members, manufacturing, quality, operations, Cell Therapy CMC and other relevant cross functional team members to ensure effective collaboration and alignment.

Requirements

• Deep expertise in cell therapy process development and analytical development
• Strong understanding of FDA CMC requirements for cell therapies
• Ability to develop and execute scientifically rigorous, regulation-compliant development strategies in a timely fashion
• 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
• Demonstrate coaching skills to develop team.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture
• 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
• Demonstrated 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
• Requires the ability to use a personal computer for extended periods of time.

Nice To Haves

• 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

Responsibilities

• 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
• Act 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.
• This position includes people management responsibilities, including day - to - day supervision, workload planning, and ensuring team members have the resources and support needed to succeed.

Benefits

• opportunity for merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• leaves provided in line with your work state
• flexible paid time off
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

What This Job Offers

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