Director/Senior Director, Drug Product/Formulation Development

3 weeks ago

South San Francisco, California, United States IDEAYA Biosciences Full time
We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development of novel early-stage processes and formulations, and the late-stage translation to commercialization of our lead products. The successful candidate will be responsible for but not limited to those activities listed below.

What You'll Do

Responsible for pre-formulation, formulation development, manufacture of clinical supplies, and development of efficient and scalable manufacturing processes.Oversight of GMP drug product manufacturing, late-stage development based on Quality by Design (QbD) and Design of Experiments (DoE), and drug product process validation/commercialization.Responsible for authoring/reviewing technical and manufacturing reports and regulatory submissions such as INDs and NDAs.Responsible for the technical and quality management of the external drug product manufacturers.Provide technical and project support for IDEAYA pipeline across all stages of research and development in terms of quality, timeline, and cost.Effectively participates in cross-functional team meetings and contributes to product development plans.
RequirementsPh. D. in Pharmaceutical Sciences or related fieldMinimum of 10 years of experience in preformulation and oral solid-dose formulation and developmentIn-depth understanding of pre-formulation, clinical formulation, biopharmaceutics principles required to get a drug from discovery through clinical development and market registrationDemonstrated track record of proactively identifying problems and driving to timely, innovative solutions to overcome challenging formulation problemsExcellent communication skills, problem solving, critical thinking, and organization skills.Ability to work in a fast-paced organization with diverse project teams and personnel.Knowledge in project management and CMC regulatory requirements
The salary range for this position is between $241,366 and $341,670. The salary range is an estimate and may vary based on the Company's compensation practices.

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