Director, CMC Process Chemistry
IDEAYA Biosciences
August 18, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary: Director, Process Chemistry (South San Francisco, CA) — onsite four days per week. Reporting to Senior Director, Head of Process Chemistry.
What you’ll do:
- Lead Process Chemistry efforts to facilitate drug substance (DS) development by managing multiple CDMOs across pre-clinical through Phase I–III and commercial; cover small molecule and ADC payload/linkers programs.
- Author/review technical development reports, batch records, campaign reports, change controls, CAPAs, deviations, and investigations.
- Author/review IND/IMPD/NDA technical sections for global CMC regulatory submissions; stay current on Health Authority guidance.
- Represent DS/CMC in cross-functional teams; manage multiple priorities and solve problems to ensure on-time DS supply for PK/PD, efficacy, DRF, pilot tox, IND-enabling, and clinical trials.
- Collaborate with Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology.
- Align DS and CMC strategies with aggressive timelines.
- Lead evaluation/selection/management of CDMOs for DS development and GMP manufacturing.
- Oversee technology transfer at CDMOs; troubleshoot and resolve issues.
Requirements:
- Ph.D. in Chemistry with 8+ years or M.Sc. with 12+ years development experience; demonstrated cross-functional leadership (late phase/commercial a plus).
- Proven delivery of DS/CMC activities (preclinical, IND-enabling, NDA material supplies, commercialization); ADC payload/linkers manufacturing experience desired.
- Strong quality systems knowledge (SOPs, batch record review/release/disposition, GDP, cGMP traceability, deviations, change management).
- Knowledge of ICH, FDA, and EMA regulatory guidance.
- Experience managing global CDMOs (dedicated FTE and FFS).
- Exceptional problem-solving; strong interpersonal/communication skills.
- Ability to multi-task in a fast-paced environment.
- Domestic and international travel to oversee DS development and manufacturing.
Total Rewards (benefits): Medical/dental/vision (100% company paid for employees; 90% for dependents), 401(k), ESPP, wellness programs.
What you’ll do:
- Lead Process Chemistry efforts to facilitate drug substance (DS) development by managing multiple CDMOs across pre-clinical through Phase I–III and commercial; cover small molecule and ADC payload/linkers programs.
- Author/review technical development reports, batch records, campaign reports, change controls, CAPAs, deviations, and investigations.
- Author/review IND/IMPD/NDA technical sections for global CMC regulatory submissions; stay current on Health Authority guidance.
- Represent DS/CMC in cross-functional teams; manage multiple priorities and solve problems to ensure on-time DS supply for PK/PD, efficacy, DRF, pilot tox, IND-enabling, and clinical trials.
- Collaborate with Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology.
- Align DS and CMC strategies with aggressive timelines.
- Lead evaluation/selection/management of CDMOs for DS development and GMP manufacturing.
- Oversee technology transfer at CDMOs; troubleshoot and resolve issues.
Requirements:
- Ph.D. in Chemistry with 8+ years or M.Sc. with 12+ years development experience; demonstrated cross-functional leadership (late phase/commercial a plus).
- Proven delivery of DS/CMC activities (preclinical, IND-enabling, NDA material supplies, commercialization); ADC payload/linkers manufacturing experience desired.
- Strong quality systems knowledge (SOPs, batch record review/release/disposition, GDP, cGMP traceability, deviations, change management).
- Knowledge of ICH, FDA, and EMA regulatory guidance.
- Experience managing global CDMOs (dedicated FTE and FFS).
- Exceptional problem-solving; strong interpersonal/communication skills.
- Ability to multi-task in a fast-paced environment.
- Domestic and international travel to oversee DS development and manufacturing.
Total Rewards (benefits): Medical/dental/vision (100% company paid for employees; 90% for dependents), 401(k), ESPP, wellness programs.