Director, CMC Process Chemistry

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Location:

South San Francisco, CA.

About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications.

Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person  are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.

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We are seeking an experienced and highly motivated Director, Process Chemistry to join our multidisciplinary team based in South San Francisco. This role requires the candidate to work collaboratively with the related cross-functional teams to support our drug discovery pipeline. The successful candidate will be responsible for but not limited to those responsibilities listed below.

This position is based in our South San Francisco headquarter offices and is required to be onsite four days per week per our company policy.

Reporting to:
Senior Director, Head of Process Chemistry.

• 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…