Director, Antibody-Drug Conjugate (ADC) Analytical

IDEAYA Biosciences • South San Francisco, CA

4d • Hybrid

About The Position

IDEAYA is a precision medicine oncology company dedicated to discovering, developing, and commercializing innovative cancer therapies. Our strategy combines expertise in small-molecule drug discovery, structural biology, and bioinformatics with strong internal capabilities for identifying and validating translational biomarkers. This allows us to develop targeted therapies that are potentially first-in-class and tailored to the genetic drivers of disease. We have a robust pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications. Our goal is to introduce the next generation of precision oncology therapies that are more selective, more effective, and highly personalized, ultimately aiming to change the course of disease and improve patient outcomes. At IDEAYA, you will be part of a team of brilliant minds working on precision medicine therapies for cancer patients. We are passionate and committed to being at the forefront of oncology medicine, which drives a high internal motivation in everyone at IDEAYA. We are inquisitive, ask profound questions, and are data-driven innovators who value collaboration and teamwork to advance science.

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 channels.

Responsibilities

• Lead Analytical for ADC Programs
• Lead 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 requirements
• Manage 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.

Benefits

• Merit-based salary increases
• Company discretionary short-term incentive plan participation
• Company discretionary stock option awards (based on board approval)
• Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• Wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree