Process Chemist Director

sumitomopharma; United States; On-site; USD 190,000 - 260,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. seeks a Director of Process Chemistry to provide senior leadership across development-stage small molecule programs.

You will shape drug-substance strategies, influence decisions in a matrixed organization, and ensure robust, scalable manufacturing approaches from early development through commercialization. You will collaborate with Analytical Development, Formulation Development, Supply Chain, QA, Regulatory, and clinical teams to support timely progress, robust

Qualifications

• Strong leadership presence with the ability to influence direction and support cross-functional programs.
• Deep scientific curiosity with a practical, risk-based development approach.
• Excellent communication to senior leadership and non-technical stakeholders.
• High organizational awareness across CMC functions.
• Strong collaboration and influencing skills in a global matrix.
• Ability to manage mul

Responsibilities

• Shape drug substance development strategies for small molecules across CMC, program, and corporate objectives.
• Provide leadership on route selection, process development, scale-up, and impurity control.
• Oversee external CDMOs with input on timelines, budgets, and deliverables.
• Contribute to phase-appropriate control strategies for starting materials, intermediates, APIs, and impurities.
• Support technology transfer to manufacturing sites and regulatory readiness activities.
• Serve as the drug substance SME for regulatory submissions and agency interactions.
• Partner with cross-functional teams to ensure integrated CMC execution and supply continuity.
• Mentor and develop scientists, fostering scientific excellence and continuous improvement.
• Contribute to portfolio strategy, due diligence, and business development as needed.
• Ensure accurate, timely, and inspection-ready documentation of development work.

Skills

Leadership presence

Cross-functional collaboration

Problem solving

Communication skills

Organizational awareness

Influencing in matrixed environments

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 or follow us on LinkedIn.

Job Overview

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.

Essential Functions Required for Job

• 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.

Knowledge, Skills and Abilities (general & technical)

• Strong leadership presence with the ability to influence direction, contribute to key technical decisions, provide sound scientific judgment, and support execution across complex, cross‑functional programs.
• Deep scientific curiosity and problem‑solving capability, with a practical and risk‑based approach to development challenges.
• Excellent communication skills, including the ability to clearly present complex technical information to senior leadership and non‑technical stakeholders.
• High degree of organizational awareness and the ability to connect interdependencies across CMC functions and broader program objectives.
• Strong collaboration and influencing skills, with success working in matrixed, global environments and with internal and external partners.
• Ability to manage mul