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IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. 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 have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as 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 established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.    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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources.  Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio.  Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com

Position Summary: We are seeking an experienced and highly motivated Director, CMC Formulation Development and Manufacturing 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 listed below. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

What you'll do:

• Lead the formulation efforts in facilitating drug development by managing multiple CDMOs across all stages of drug development (pre-clinical, Phase I – III, and commercial)
• Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigation.
• Author and review necessary technical sections in IND/IMPD/NDA supporting global CMC regulatory submission and remain current on Health Authority guidance and expectations.
• Develop DP strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
• Represent DP/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 drug 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, Process Chemistry, 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 DP and CMC strategies to achieve and maintain aggressive timelines to ensure goals are met
• Lead dosage form selection, formulation development, process optimization, and scale-up activities, ensure robust, cost-effective, and scalable manufacturing processes.
• Lead the evaluation, selection, and management of CDMOs to perform formulation and process 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 Pharmaceutics, Chemistry, Chemical Engineering or related discipline with a minimum of (12) years or M.S with a minimum of (15) years of development experience and demonstrated ability in leading cross-functional groups. Late phase and commercial experience are a plus.
• Demonstrated track record of success in delivering timely execution of DP and CMC activities ranging from preclinical, IND-enabling and NDA material supplies, through GMP clinical trial supplies and commercialization.
• Demonstrated expertise in small molecule formulation development (traditional oral solid dosage and enabling formulations such as ASD and HME is a plus), scale-up and manufacturing, and phase appropriate control strategy and specification development.
• Experience with analytical techniques for small molecules and oral solid dose products, with proficiency in UPLC/HPLC, dissolution, and solid-state characterization techniques such as DSC/TGA, PLM, XRPD and laser diffraction PSD method.  Track records to interpretate the analytical data and application to support formulation development.
• Good understanding of physico-chemical properties of API, PK/PD correlation and develop the phase appropriate formulations
• Strong understanding of Quality systems including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
• Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia
• Experience in managing global CDMOs and reviewing documentation and ensuring proper guidelines are followed.
• 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
• Excellent interpersonal communication and decision-making skills
• Able to travel domestic and internationally to oversee DP development and manufacturing at CDMOs