Process Chemist Director

US-Remote

Full time

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  or follow us on Linked In.

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 an 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.

• 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,…