Director, Process Chemistry & CMC Leadership

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 206,000 - 254,000; Full time

Benefits offered by this job

Medical/dental/vision

401k

ESPP

Wellness programs

Job summary

IDEAYA Biosciences is seeking a Director of Process Chemistry to lead DS development and manage CDMOs across discovery, development, and early commercial stages. This onsite role requires collaboration with multiple functions to align DS/CMC strategies and ensure timely supply for studies and trials.

The position reports to the Senior Director and is based in South San Francisco, requiring domestic and international travel as needed. A Ph.D.

Qualifications

• Ph.D. in Chemistry with 8+ years (12+ with MSc) development experience and cross-functional leadership.
• Experience delivering DS/CMC activities from preclinical to NDA materials; ADC payload/linker experience is a plus.
• Strong understanding of cGMP, QA, batch records, deviations and change management.
• Familiarity with ICH, FDA, EMA guidelines and global CDMO management.
• Willingness to travel domestically and internationally; excellent communication and collaboration skills.

Responsibilities

• Lead DS development and manage multiple CDMOs across preclinical, Phase I–III, and commercial stages.
• Author and review development reports, batch records, campaign reports, change controls, deviations, and investigations.
• Prepare technical sections for IND/IMPD/NDA submissions and stay current on regulatory expectations.
• Collaborate with cross-functional teams to align DS/CMC strategies and schedules.
• Oversee technology transfer at CDMOs and troubleshoot manufacturing issues.

Skills

Process Chemistry leadership

CDMO management

CMC regulatory submissions

Cross-functional collaboration

IND/IMPD/NDA support

Global teamwork

Education

Ph.D. in Chemistry

M.Sc. in Chemistry

Job description

IDEAYA Biosciences is seeking a Director of Process Chemistry to lead DS development and manage CDMOs across discovery, development, and early commercial stages. This onsite role requires collaboration with multiple functions to align DS/CMC strategies and ensure timely supply for studies and trials.

The position reports to the Senior Director and is based in South San Francisco, requiring domestic and international travel as needed. A Ph.D.