Director, CMC Formulation Development and Manufacturing
IDEAYA Biosciences
July 01, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
What you’ll do:
- Lead formulation efforts by managing multiple CDMOs across pre-clinical, Phase I–III, and commercial stages.
- 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 submissions; stay current with Health Authority guidance.
- Develop DP strategies to meet program/project targets and enable timely regulatory approvals.
- Represent DP/CMC on cross-functional teams; manage multiple priorities and resolve issues to ensure on-time supply for PK/PD, efficacy, DRF, pilot tox, IND-enabling, and clinical trials.
- Lead dosage form selection, formulation development, process optimization, and scale-up; ensure robust, cost-effective, scalable manufacturing.
- Evaluate/select/manage CDMOs for formulation, process development, and GMP manufacturing.
- Oversee CDMO technology transfer and provide technical troubleshooting.
Requirements:
- Ph.D. (12+ years) or M.S. (15+ years) in Pharmaceutics/Chemistry/Chemical Engineering or related; demonstrated ability leading cross-functional groups (late phase/commercial a plus).
- Track record delivering DP/CMC from preclinical/IND-enabling through GMP clinical supplies and commercialization.
- Expertise in small-molecule formulation development, scale-up/manufacturing, and phase-appropriate control strategy/specs.
- Experience with UPLC/HPLC, dissolution, and solid-state characterization (e.g., DSC/TGA, PLM, XRPD, laser diffraction/PSD).
- Knowledge of API physico-chemical properties, PK/PD correlation.
- Strong quality systems knowledge (SOPs, batch release/disposition, GDP, cGMP traceability, deviations, change management).
- Regulatory/compendial standards (ICH, FDA, MHRA, EMA; USP-NF, Ph. Eur, BP, JP).
- Experience managing global CDMOs and reviewing documentation.
- Exceptional problem-solving; excellent communication; ability to multitask in fast-paced environments; domestic/international travel.
Total Rewards/Benefits (as stated):
- Salary range: $215,000–$266,000.
- Medical/dental/vision, 401k, ESPP, wellness programs; merit-based increases and discretionary short-term incentive/stock options (based on board approval).
Location/Worksite:
- South San Francisco, CA; onsite four days per week.
- Lead formulation efforts by managing multiple CDMOs across pre-clinical, Phase I–III, and commercial stages.
- 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 submissions; stay current with Health Authority guidance.
- Develop DP strategies to meet program/project targets and enable timely regulatory approvals.
- Represent DP/CMC on cross-functional teams; manage multiple priorities and resolve issues to ensure on-time supply for PK/PD, efficacy, DRF, pilot tox, IND-enabling, and clinical trials.
- Lead dosage form selection, formulation development, process optimization, and scale-up; ensure robust, cost-effective, scalable manufacturing.
- Evaluate/select/manage CDMOs for formulation, process development, and GMP manufacturing.
- Oversee CDMO technology transfer and provide technical troubleshooting.
Requirements:
- Ph.D. (12+ years) or M.S. (15+ years) in Pharmaceutics/Chemistry/Chemical Engineering or related; demonstrated ability leading cross-functional groups (late phase/commercial a plus).
- Track record delivering DP/CMC from preclinical/IND-enabling through GMP clinical supplies and commercialization.
- Expertise in small-molecule formulation development, scale-up/manufacturing, and phase-appropriate control strategy/specs.
- Experience with UPLC/HPLC, dissolution, and solid-state characterization (e.g., DSC/TGA, PLM, XRPD, laser diffraction/PSD).
- Knowledge of API physico-chemical properties, PK/PD correlation.
- Strong quality systems knowledge (SOPs, batch release/disposition, GDP, cGMP traceability, deviations, change management).
- Regulatory/compendial standards (ICH, FDA, MHRA, EMA; USP-NF, Ph. Eur, BP, JP).
- Experience managing global CDMOs and reviewing documentation.
- Exceptional problem-solving; excellent communication; ability to multitask in fast-paced environments; domestic/international travel.
Total Rewards/Benefits (as stated):
- Salary range: $215,000–$266,000.
- Medical/dental/vision, 401k, ESPP, wellness programs; merit-based increases and discretionary short-term incentive/stock options (based on board approval).
Location/Worksite:
- South San Francisco, CA; onsite four days per week.