Associate Director, CMC Analytical Chemistry

Company: Exokeryx, Inc.
Location: San Francisco
Posted on: January 21, 2025

Job Description:

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. 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 have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as 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.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 teamwork to move science forward.Position Summary:We are seeking an experienced and highly motivated Associate Director, CMC Analytical Chemistry to join our multidisciplinary team based in South San Francisco. The 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 listed below.This position is based in our South San Francisco headquarters and requires onsite presence four days per week per our company policy.What you'll do:

• Lead the analytical chemistry efforts in facilitating drug development by managing multiple CDMOs across all stages of drug development (pre-clinical, Phase I - III, and commercial) for drug substance and drug product.
• Oversee analytical activities at multiple CDMOs, ensuring high productivity, quality, and scientific rigor.
• Provide analytical support for Process Chemistry and Formulation Development as needed.
• Ensure existing methods are technically sound, well developed, and fit-for-purpose.
• Provide expertise to CDMOs to facilitate troubleshooting methods and provide technical guidance across programs.
• Conduct analytical technical review of QC data generated at CDMOs for release, stability, and method validations.
• Provide analytical expertise for deviations and OOS/OOT investigations while working closely with Quality Assurance.
• Draft necessary technical sections in IND/IMPD/NDA supporting global CMC regulatory submissions.
• Interface effectively with other scientific disciplines (e.g., Quality Assurance, Analytical Chemistry, DMPK, Process Chemistry, and Formulation Development).
• Ability to ensure analytical method qualification/validation/technical-transfer documentation (test protocols, methods, and reports) are phase appropriate, accurate, and complete.
• Proactively communicate with and work closely with other functions to align analytical strategies to achieve and maintain aggressive timelines to ensure goals are met.Requirements:
  • Ph.D. in analytical chemistry or related discipline with a minimum of (8) years of drug development experience, or M.S./B.S. with a minimum of (15) years of development experience and demonstrated ability in leading cross-functional groups. Late phase and commercial experience are a plus.
  • Strong subject matter expertise in separation, mass spectrometry, structural elucidation, chemical analysis, analytical method development/validation, and CDMO management.
  • Thorough understanding in analytical techniques to support pipeline programs using NMR, HPLC, UPLC, UV, CAD, GC, GC-MS, LC-MS, SFC, PSD, KF, and dissolution.
  • Demonstrated record of excellence in leadership and management in a small molecule drug development industry environment.
  • Expert knowledge in cGMP compliance, ICH guidelines, compendial standards, and different health authority regulations across the world pertaining to analytical activities such as control strategies, method validations, and product specifications.
  • Experience in managing international CDMOs and reviewing documentation and ensuring proper guidelines are followed.
  • 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.Salary: $214,900 - $220,150 a yearAt IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office is $214,900 - $220,150.The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.Total Rewards:Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, 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. EOE/AA/Vets.
    #J-18808-Ljbffr

Keywords: Exokeryx, Inc., San Jose , Associate Director, CMC Analytical Chemistry, Executive , San Francisco, California