IDEAYA Biosciences (NASDAQ: IDYA) 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.
IDEAYA has an industry leading platform and pipeline in Synthetic Lethality. IDEAYA has established strategic collaborations with Amgen and Pfizer supporting its pipeline programs, and also has wholly-owned or controlled clinical and preclinical programs. For more information, please see www.ideayabio.com
We are seeking a talented and highly motivated Associate Director / Director, Process Chemistry
with significant pharmaceutical industry experience and innovation to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related cross-functional teams to support drug discovery, IND-enabling studies, CMC IND/IMPD and NDA/MAA filings, and GMP API manufacturing and supply. The successful candidate will be responsible for but not limited to those activities listed below.
What you'll do
- Contribute to the process chemistry efforts in facilitating medicinal chemistry research by overcoming synthetic bottlenecks to chemical intermediates and active pharmaceutical ingredients (API) and streamlining SAR.
- Accountable for new route design and development/implementation of phase appropriate and robust synthetic processes to successfully deliver preclinical and clinical API batches
- Responsible for all activities related to process develop and validation for our programs in the clinical and commercialization stages
- Perform vendor / CMO review and selection, in addition to management of process development and manufacturing activities at CMOs
- Work closely with regulatory affairs to author CMC sections in the IND/IMPD and NDA/MAA filings
- Participate in proactive resourcing planning, contract/agreement negotiations, and budget management
- Represent CMC in the core and sub-functional teams; responsible for strategic planning, risk-assessment, timeline tracking and implementation in pre-clinical and clinical stages
- Ph.D. in organic chemistry with 7+ years, or M.Sc. with 10+ years of drug discovery/development experience and demonstrated ability in leading cross-functional groups
- Experience in late-phase process development (Registrational and Validation Campaigns) and knowledge of NDA fillings is desirable, but not required.
- Strong subject matter expertise in process development, solid state characterization, cGMP manufacturing and CMO management
- Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed
- Excellent interpersonal, communication, and collaboration skills
- Demonstrated ability in strategic planning and prioritization of a portfolio of projects
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
- Ability to mentor junior level CMC scientists and supporting team members
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
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.
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.California Job Applicant Privacy Notice