- 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.
Requirements - Ph. D. in Pharmaceutical Sciences or related field
- Minimum of 10 years of experience in preformulation and oral solid-dose formulation and development
- In-depth understanding of pre-formulation, clinical formulation, biopharmaceutics principles required to get a drug from discovery through clinical development and market registration
- Demonstrated track record of proactively identifying problems and driving to timely, innovative solutions to overcome challenging formulation problems
- Excellent 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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Director/Senior Director, Drug Product/Formulation Development - South San Francisco, United States - IDEAYA Biosciences
Description
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
