Director, CMC Process Chemistry

IDEAYA Biosciences•South San Francisco, CA

4d•$206,000 - $254,000•Hybrid

About The Position

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 at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com. Location: South San Francisco, CA. Position Summary: 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

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

Nice To Haves

Late phase and commercial experience are a plus.
Experience in the manufacture of ADC payload/linkers is desired.

Responsibilities

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.