- 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.
- 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
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Director/Senior Director, Drug Product/Formulation Development - San Francisco, United States - IDEAYA Biosciences, Inc.
Description
IDEAYA 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 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 precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.
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.
For more information, please see
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
Requirements:
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.
Benefits
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs.
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.
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