Executive Director, Cell Therapy Process and Analytical Development

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 womens 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 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-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.

Knowledge Skills and Abilities (general & technical):

• 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

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
• 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
• 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

Travel Requirements:

This is an 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.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Ability to influence to drive to decisions. Excellent written and oral communication skills are required. Requires the ability to use a personal computer for extended periods of time.

People Management

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.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases short incentive plan participation eligibility for our 401(k) plan medical dental vision life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off 11 paid holidays plus 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. Total compensation including base salary to be offered will depend on elements unique to each candidate including candidate experience skills education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities duties and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

Confidential Data: All information (written verbal electronic etc.) that an employee encounters is considered confidential in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the best industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field manufacturing or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital domestic partnership or civil union status; sex gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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