Director of Process Chemistry – Small Molecule API

Socket.dev; United States; Remote; USD 207,000 - 259,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Life and disability insurance

Flexible PTO

Holidays

Job summary

Sumitomo Pharma America, Inc. seeks a Director of Process Chemistry to lead drug substance development across early to late-stage programs.

You will influence route selection, scale-up, impurity strategy, and technology transfer in a highly matrixed environment, reporting to the VP, CMC Development. You will mentor scientists, oversee CDMOs, and ensure readiness for regulatory submissions while collaborating with Regulatory, Analytical, QA, and Clinical teams.

Qualifications

• PhD in Organic Chemistry or related field; exceptional candidates with a Master’s or Bachelor’s degree may be considered.
• At least 10 years of pharma/biotech process chemistry or drug substance development experience.
• Proven leadership in cross-functional, matrixed environments within CMC and development settings.

Responsibilities

• Shape drug substance development strategies for small molecule programs and align with CMC, program, and corporate objectives.
• Provide leadership on route selection, process development, scale-up, and impurity control with data-driven input.
• Oversee external process development/manufacturing activities at CDMOs and guide timelines and budgets.
• Develop phase-appropriate control strategies for starting materials, intermediates, APIs, impurities.
• Support technology transfer to manufacturing sites and contribute to regulatory readiness efforts.
• Act as drug substance subject matter expert for regulatory submissions and health authority interactions.

Skills

Leadership

Cross-functional leadership

Regulatory knowledge

cGMP experience

Project management

Education

PhD in Organic Chemistry

Job description

Sumitomo Pharma America, Inc. seeks a Director of Process Chemistry to lead drug substance development across early to late-stage programs.

You will influence route selection, scale-up, impurity strategy, and technology transfer in a highly matrixed environment, reporting to the VP, CMC Development. You will mentor scientists, oversee CDMOs, and ensure readiness for regulatory submissions while collaborating with Regulatory, Analytical, QA, and Clinical teams.