Director, CMC Process Chemistry
- Employer
- IDEAYA Biosciences
- Location
- South San Francisco, CA
- Posted date
- Sep 28, 2026
View more categories
- Discipline
- Engineering, Manufacturing & Production, Science/R&D, Process Engineer, Process, Chemistry, CMC
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay
By clicking apply, your email address will be shared with the employer.
Job Details
Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.
Job Summary
Job Description
What you’ll do:
Lead Process Chemistry efforts in facilitating drug substance (DS) development by managing multiple CDMOs across all stages of drug development (pre-clinical, Phase I – III, and commercial). This position will be responsible for traditional small molecule and ADC payload/linkers programs.
Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations.
Author and review necessary technical sections in IND/IMPD/NDA supporting global CMC regulatory submissions and remain current on Health Authority guidance and expectations.
Represent DS/CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of DS to support PK/PD, efficacy, DRF and pilot toxicology studies, IND-enabling activities, and clinical trials across a portfolio of programs.
Collaborate closely in cross-functional teams including but not limited to Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology to achieve project goals.
Proactively communicate with and work closely with other functions to align DS and CMC strategies to achieve and maintain aggressive timelines to ensure goals are met.
Lead the evaluation, selection, and management of CDMOs to perform DS development, and GMP manufacture.
Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary.
Requirements:
Ph.D. in Chemistry with a minimum of 8 years or a M.Sc. with a minimum of 12 years of development experience and demonstrated ability in leading cross-functional groups. Late phase and commercial experience are a plus.
Track record of success in delivering timely execution of DS and CMC activities ranging from preclinical, IND-enabling and NDA material supplies and commercialization. Experience in the manufacture of ADC payload/linkers is desired.
Strong understanding of Quality systems including SOPs, manufacturing batch record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
Established knowledge and application of current industry standards and regulatory authority guidance and expectations, including ICH, FDA, and EMA guidelines.
Experience managing global CDMOs, both dedicated FTE teams and FFS projects.
Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed.
Excellent interpersonal and communication skills for internal and external collaborations.
Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic.
Able to travel domestically and internationally to oversee DS development and manufacturing at CDMOs.
All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.
Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels
Total Rewards
Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.
The expected salary range for the roleof Director, CMC Process Chemistry is $206,000 - $254,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.
The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.
Company
Founded in 2015, IDEAYA Biosciences is a public, clinical-stage synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response.
Stock Symbol: IDYA
- Phone
- 650-443-6209
- Location
- 5000 Shoreline Court, Ste. 300
South San Francisco
California
94080