Senior Director, ADC Process Development

Role Summary

Senior Director, ADC Process Development responsible for leading and expanding a multidisciplinary team delivering Lilly’s Antibody-Drug Conjugate (ADC) portfolio. Drives end-to-end development of small molecule payloads, linkers, and conjugation processes from preclinical through commercial, at the intersection of chemistry, engineering, and biologics.

Responsibilities

• Build and lead a multidisciplinary team of scientists and engineers, managing resources to meet project and program objectives.
• Develop and implement short- and long-term CMC strategies to support a growing portfolio pipeline, while balancing internal and external resource requirements and constraints.
• Collaborate with internal stakeholders (e.g., Discovery, Analytical, Drug Product, Quality, Regulatory, CMC PM) and external CDMOs to align and execute the CMC development plan.
• Create and update end-to-end capacity models, provide important data for business planning.
• Drive the design, scale-up, and tech transfer of small molecule payload and linker synthesis processes in support of ADC development.
• Oversee development and optimization of conjugation processes for early and late-stage clinical projects.
• Work with HSE to establish and enforce safety protocols for handling ADC payloads, linkers, and conjugates in development labs.
• Contribute to regulatory submissions (IND, IMPD, BLA/MAA), authoring high-quality CMC sections.
• Help drive innovation and evaluate emerging technologies to enhance platform capabilities.

Qualifications

• Ph.D. and M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.
• A minimum of 8 years of industry experience (with a Ph.D.) or 15 years (with an M.S.) in small molecule process development.
• Demonstrated experience leading technical teams and managing people, ideally across multiple functions.
• Strong track record of successful IND/IMPD/BLA submissions and regulatory interactions.
• Deep understanding of CMC workflow, process development and scale-up, tech transfer, and GMP manufacturing.
• Excellent engagement, communication, leadership, and organizational skills.

Skills

• Experience with linker-payload design and conjugation technologies for ADCs.
• Experience with regulatory filings for ADC projects.
• Expertise in handling high-potency APIs in laboratory and GMP settings.
• Experience working in a matrixed biotech/pharma environment or with external partners.

Additional Requirements

• Accommodation support available for applicants; information provided by employer as part of process per policy.