Process Chemist Director

Sumitomo Pharma•Marlborough, MA

13d•Remote

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. The Director, Process Chemistry provides senior process chemistry expertise and technical leadership across development-stage small molecule programs, with the ability to evaluate, shape, and influence process chemistry decisions in a collaborative, matrixed environment reporting to the VP, CMC Development. The Director plays in active role in developing robust, scalable, and phase-appropriate drug substance manufacturing approaches from early development through commercialization, including route scouting, process optimization, impurity control strategy, scale-up, technology transfer, and external manufacturing oversight. This position works closely with internal and external partners across Analytical Development, Formulation Development, Supply Chain, Quality, Regulatory, and project teams to support timely progression of programs, reliable clinical and commercial supply, and successful regulatory submissions. This is a highly cross-functional role requiring strong scientific judgment, operational leadership, and the ability to influence decisions through expertise, collaboration, and trusted partnership across a matrixed global organization.

Requirements

PhD in Organic Chemistry, Process Chemistry, Pharmaceutical Chemistry, or a related scientific discipline required; exceptional candidates with a Master’s or Bachelor’s degree and significant relevant industry experience may be considered.
A minimum of 10 years of relevant pharmaceutical or biotechnology industry experience in process chemistry or drug substance development, including meaningful experience providing technical leadership in cross-functional or matrixed settings.
Demonstrated expertise in synthetic route design, process optimization, scale-up, impurity control, and technology transfer for small molecule APIs.
Strong working knowledge of cGMP manufacturing, CMC development, regulatory expectations, and global quality standards relevant to drug substance development.
Experience authoring or reviewing regulatory submission content and supporting health authority interactions for drug substance sections.
Proven success working with external partners such as CDMOs and contract laboratories to provide technical oversight, identify risks, and influence high-quality outcomes on time and within budget.
Experience working in cross-functional teams supporting programs from early development through late-stage development and/or commercialization.
Ability to travel periodically as needed for CDMO visits, technical oversight, and internal meetings.
Ability to work effectively in a global, matrixed organization, including collaboration with international colleagues, external partners, and cross-functional stakeholders.

Nice To Haves

Prior people management experience is preferred, though strong matrix leadership experience will also be considered.
Japanese language proficiency is a plus and would enhance collaboration and technical communication with Japanese colleagues engaged in global CMC development strategy and execution.

Responsibilities

Demonstrate leadership ability to shape drug substance development strategies for small molecule programs, bringing process chemistry expertise to support sound, aligned decisions across CMC, program, and corporate objectives.
Provide scientific and technical leadership on route selection, process development, optimization, control strategy, and scale-up, influencing clinical and commercial manufacturing decisions through data-driven recommendations and expert judgment.
Support oversight of external process development and manufacturing activities at CDMOs by providing technical input, risk identification, issue-resolution recommendations, and guidance on timelines, budgets, and deliverable quality.
Contribute to phase-appropriate control strategies for starting materials, intermediates, APIs, impurities, and critical process parameters in collaboration with Analytical Development, Quality, and other cross-functional stakeholders.
Provide technical input to technology transfer activities to manufacturing sites and support engineering, registration, validation, and commercial readiness activities as applicable.
Operate as a drug substance subject matter expert for regulatory submissions and agency interactions, including providing technical input and reviewing relevant sections of INDs, IMPDs, CTDs, NDAs MAAs, and responses to health authority questions.
Partner closely with cross-functional teams including Formulation Development, Analytical Development, Supply Chain, QA, Regulatory Affairs, and clinical teams to ensure integrated CMC execution and uninterrupted supply.
Facilitate scientific problem solving related to process performance, manufacturability, impurity trends, robustness, and lifecycle improvements by providing data-driven recommendations and influencing alignment.
Build and maintain strong relationships with external partners, consultants, and contract laboratories to advance development objectives effectively and efficiently.
Mentor, coach, and develop scientists or matrix team members, while fostering a culture of scientific excellence, accountability, collaboration, and continuous improvement.
Contribute to portfolio strategy, due diligence, and business development assessments as needed.
Ensure accurate, timely, and inspection-ready documentation of development work, technical reports, and governance updates.