Director, Process Chemistry & DS/CMC Lead

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

Benefits offered by this job

Medical coverage

401k

Stock options

Job summary

IDEAYA Biosciences is seeking a Director, CMC Process Chemistry to lead drug-substance development from discovery through NDA, based in South San Francisco. The role requires strong cross-functional collaboration to align DS and CMC strategies and ensure timely supply for PK/PD and toxicology studies.

The ideal candidate has a PhD in Chemistry with 8+ years of leadership, experience with ADC payload/linkers and cGMP, and a track record in regulatory submissions and global CDMO management.

Qualifications

• Ph.D. in Chemistry with 8+ years development leadership experience; late phase/commercial a plus.
• Proven track record delivering DS/CMC activities from preclinical to NDA materials.
• Strong knowledge of cGMP, QA, batch release, Deviations and Change Management.
• Experience managing global CDMOs and regulatory interactions (FDA/EMA).

Responsibilities

• Lead DS development and manage multiple CDMOs across all stages of drug development.
• Author/review technical sections for IND/IMPD/NDA submissions and change controls.
• Coordinate DS/CMC strategies with cross-functional teams to meet aggressive timelines.
• Oversee technology transfer and manufacturing at CDMOs; troubleshoot issues as needed.
• Collaborate with Medicinal Chemistry, DMPK, Analytical Chemistry, and Regulatory to hit milestones.

Skills

Cross-functional leadership

CDMO management

Regulatory knowledge

Communication skills

Problem solving

Education

Ph.D. in Chemistry

M.Sc. in Chemistry

Job description

IDEAYA Biosciences is seeking a Director, CMC Process Chemistry to lead drug-substance development from discovery through NDA, based in South San Francisco. The role requires strong cross-functional collaboration to align DS and CMC strategies and ensure timely supply for PK/PD and toxicology studies.

The ideal candidate has a PhD in Chemistry with 8+ years of leadership, experience with ADC payload/linkers and cGMP, and a track record in regulatory submissions and global CDMO management.