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 multiple priorities, adapt to changing business needs, and maintain focus on quality, timelines, and outcomes.
• Commitment to developing talent, building effective teams, and fostering an inclusive and accountable work environment.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.

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

Travel Requirements:

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

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.

People Management

This is an individual contributor role and does not have direct reports or formal people-management responsibilities.

Travel Requirements:

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

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.

The base salary range for this role is

$207,000.00 - $258,700.00

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.