Director, CMC Process Chemistry — Onsite SF

BioSpace; South San Francisco (CA); On-site; USD 206,000 - 254,000; Full time

Job summary

IDEAYA Biosciences, based in South San Francisco, CA, seeks a Director of Process Chemistry to lead DS development and manage CDMOs across drug development stages. The role is onsite four days per week, reporting to the Senior Director, Head of Process Chemistry.

The successful candidate will collaborate with Medicinal Chemistry, DMPK, Analytical Chemistry, and other functions to deliver DS/CMC milestones, ensure regulatory alignment, and drive timely manufacture for preclinical to NDA programs.

Qualifications

• Ph.D. in Chemistry with 10+ years in chemical process development in a pharmaceutical/biotech setting.
• Proven ability to lead cross-functional groups and manage global CDMOs.
• Experience delivering DS/CMC activities from preclinical through NDA with regulatory familiarity.

Responsibilities

• Lead DS development by managing multiple CDMOs across all stages of drug development.
• Author and review IND/IMPD/NDA technical sections and regulatory submissions.
• Collaborate with cross-functional teams to align DS/CMC strategies and meet aggressive timelines.
• Oversee technology transfer and troubleshooting at CDMOs to ensure GMP manufacturing.
• Support PK/PD, efficacy studies, DRF, and clinical trials through DS supply.

Skills

Cross-functional leadership

CDMO management

Problem-solving

Interpersonal communication

Travel readiness

Education

Ph.D. in Chemistry

M.Sc. in Chemistry

Job description

IDEAYA Biosciences, based in South San Francisco, CA, seeks a Director of Process Chemistry to lead DS development and manage CDMOs across drug development stages. The role is onsite four days per week, reporting to the Senior Director, Head of Process Chemistry.

The successful candidate will collaborate with Medicinal Chemistry, DMPK, Analytical Chemistry, and other functions to deliver DS/CMC milestones, ensure regulatory alignment, and drive timely manufacture for preclinical to NDA programs.