Director, CMC Process Chemistry
- Compensation
- Not disclosed
- Location
- South San Francisco HQ
- Work setup
- Remote
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 8+ years
- Category
- Not specified
- Posted
Skills
Must have
- Ph.D. in Chemistry with a minimum of 8 years or a M.Sc. with a minimum of 12 years of development experience and demonstrated ability in leading cross-functional groups. Late phase and commercial expe
- Track record of success in delivering timely execution of DS and CMC activities ranging from preclinical, IND-enabling and NDA material supplies and commercialization. Experience in the manufacture of
- Strong understanding of Quality systems including SOPs, manufacturing batch record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change M
- Established knowledge and application of current industry standards and regulatory authority guidance and expectations, including ICH, FDA, and EMA guidelines.
- Experience managing global CDMOs, both dedicated FTE teams and FFS projects.
- 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.
- Able to travel domestically and internationally to oversee DS development and manufacturing at CDMOs.
Full description
Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.
Job Summary
About IDEAYA Biosciences:
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
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 www.ideayabio.com.
Location: South San Francisco, CA.
Position Summary:
We are seeking an experienced and highly motivated Director, Process Chemistry 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 responsibilities listed below.
This position is based in our South San Francisco headquarter offices and is required to be onsite four days per week per our company policy.