Director/Senior Director, Drug Product/Formulation Development
3 weeks ago
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. 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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South San Francisco, California, United States IDEAYA Biosciences Full timeWe 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...
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South San Francisco, United States IDEAYA Biosciences Full timeIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage 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...
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South San Francisco, California, United States IDEAYA Biosciences Full timeIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage 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...
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South San Francisco, United States BioSpace Full timeJob DetailsIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage 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...
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