Director, Antibody-Drug Conjugate (ADC) Analytical

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We ask that you only email your interest once.Job SummaryAbout 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 South San Francisco, CA.Position Summary:The Director, ADC Analytical will have responsibility for managing analytical development, assay transfer, release, stability, and characterization/comparability, and BLA/launch preparation activities pertaining to analytical testing at CDMOs for IDEAYA’s antibody–drug conjugate (ADC) platform and pipeline. This role will be an integral part of a team built to execute the CMC strategy required to advance ADC programs through clinical development and successfully enable global commercial launch and post-approval supply.This position requires a seasoned Analytical Development professional with technical experience in antibody/ADC development, capable of collaborating effectively with internal and external subject matter experts. The successful candidate has strong execution capability across clinical and commercial stages, and experience operating within a predominantly outsourced manufacturing model while supporting development of internal capabilities.This role reports to the VP, ADC Development and Manufacturing and is based in IDEAYA’s South San Francisco, California office, with an expectation to be in the office 4 days a week.Reporting to: Vice President, ADC Development and ManufacturingJob DescriptionWhat you’ll do:Lead Analytical for ADC ProgramsLead analytical activities to support Phase 1–3 clinical development, facilitating clinical supply, process evolution, and change management.Provide technical oversight for outsourced analytical method development, transfer, qualification, validation, and characterization of Mab intermediate, ADC DS and DP.Perform review of in-process, batch release, and stability data to support cGMP manufacturing and regulatory requirementsManage multiple outsourced workstreams to enable timely, compliant testing, release, and characterization of ADC drug substance, drug product, and MAb intermediate to meet clinical demand and regulatory requirements for ADC clinical and commercial programs.Manage execution of pre-commercial analytical activities, including analytical validation, stability programs supporting expiry and manufacturing changes, extended characterization, and commercial control strategies.Support post-approval lifecycle management, including process optimization, site changes, scale expansion, and regulatory variations.Serve as technical SME for selection of CDMOs supporting clinical and commercial manufacturing for ADC programs.Provide technical expertise for IND/CTA and BLA/MAA submissions and health authority interactions.Thrive in a culture of accountability, scientific excellence, and cross-functional collaboration.Requirements:MS/PhD in Biochemistry, Biotechnology, or related discipline (or equivalent experience).10+ years of experience in biologics and/or ADC analytical development and manufacturing, with significant experience supporting early-to-late-stage clinical development.Extensive experience managing CDMO activities.Technical expertise in ADC analytics and validation supporting MAb intermediate and ADC DS/DP characterization, stability, and release testing.Experience supporting BLA/MAA submissions and regulatory inspections.Proven technical leadership with strong cross-functional influence.Collaborative and execution oriented.Excellent communication skills with the ability to understand, effectively present, and drive towards solutions for technical challenges.Experience developing robust analytical programs for oncology biologics.All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channelsTotal RewardsAlong 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.The expected salary range for the role of Director, ADC Analytical is $206,000 - $254,000. 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. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with 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.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.We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at View email address on click.appcast.io. #J-18808-Ljbffr Ideaya-Biosciences