Sumitomo Pharma Co. , Ltd.
pharmaceutical
ExecutiveDirector,CellTherapyProcessandAnalyticalDevelopment
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“Executive Director, Cell Therapy Process and Analytical Development at Sumitomo Pharma Co. , Ltd.. Skills: Cell Therapy Process Development, Analytical Development, Regulatory Submissions, Team Leadership. Lead and provide strategic alignment. Drive strategic planning and scientific strategy”
What You'll Achieve.
Deliver program and platform outcomes; Meet current and future portfolio needs; Enable compliant, timely delivery
Industry & Context.
Critical thinking and problem-solving ability; Integrate Lean Six Sigma approaches to processes; In depth experience in leading complex root cause analysis
Onsite role at our Morrisville, NC Cell Processing Center, Employees based in North Carolina onsite may need to travel up to 25% of the time as required both domestically and internationally, Fast-paced environment handling multiple demands, Must be able to exercise appropriate judgment as necessary, Requires a high level of initiative and independence, Ability to influence to drive to decisions, Requires the ability to use a personal computer for extended periods of time, Primarily remote role with periodic on-site meetings in office, Must be able to travel domestically and internationally as needed, Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test
What They're Looking For.
Must Have
Ph. D. in Cell Biology, Molecular Biology, Biochemistry, or a related scientific discipline, 15+ years of direct industry experience in pharmaiotech, 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
Nice to Have
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
What You'll Do.
Lead and provide strategic alignment
Drive strategic planning and scientific strategy
Lead and manage Process and Analytical Development laboratories
Develop and execute phase-appropriate experimental strategies
Partner cross-functionally with Manufacturing
Actively participate as a member of the site leadership team
Act as a key liaison between the NC-CPC laboratories
Communicate updates on functional assay development and performance
Lead technical strategy and execution for regulatory submissions
Shape and drive key Cell Therapy development and long-term platform strategy
How You'll Work.
Team & Collaboration
Works closely with CPC based team members, manufacturing, quality, operations, Cell Therapy CMC; Ensure effective collaboration and alignment; Partner cross-functionally with Manufacturing, MS&T, Quality, Regulatory, Operations, Supply Chain, Finance and Human Resources; 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; Partner with key cross-functional stakeholders and subject matter experts
Communication Scope
Excellent written and oral communication skills
Process & Methodology
Strategic planning, Resource prioritization, Governance of key technical decisions, Proactive risk assessment and mitigation, Negotiating priorities, timelines, scope, and resourcing, Escalating trade-offs
Full Job Description
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. For more information on SMPA, visit our website [_https://www.us.sumitomo-pharma.com_](https://www.us.sumitomo-pharma.com) or follow us on LinkedIn. 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. Essential Functions Required for Job * 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-
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