Sr. Director, ADC Drug-Linker Synthetic Process Development

Lilly • Indianapolis, IN

44d

About The Position

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The current opportunity is within the Bioproduct Research and Development (BR&D) organization, which is a multidisciplinary organization focused on the development and commercialization of biologic therapeutics such as monoclonal antibodies and bioconjugates. Due to a strategic commitment to the growth of novel modalities such as Antibody-Drug Conjugates (ADCs) and an exciting pipeline of investigational medicines within the Lilly portfolio, we are seeking outstanding candidates to work at this exciting small molecule – biologics interface, focusing on small-molecule drug-linker synthetic chemistry. The successful candidate will interface closely with the biologics development in BR&D and with the Synthetic Molecule Design and Development organization (SMDD) at Lilly.

Requirements

• Ph.D. in synthetic organic chemistry or relevant scientific discipline with > 8 years of experience; B.S. or M.S. with 15+ years of demonstrated equivalent experience in a related field of expertise.
• Proven leadership experience managing small molecule CMC development programs and leading scientific teams through all stages of development from discovery handoff to GMP manufacturing and regulatory submission.
• Extensive expertise and scientific knowledge in linker design, payload chemistry, and related bioconjugation strategies.
• Proven ability to drive innovation in ADC or small molecule process development, with a focus on implementing novel technologies, improving efficiency, and solving complex scientific challenges.
• Experience in preparing and contributing to regulatory filings, including IND, IMPD, and BLA submissions, with responsibility for drafting and reviewing CMC-related documentation.

Nice To Haves

• Experience working in high-potency laboratory environments, including the development of containment strategies and implementation of occupational safety practices, is highly desirable.
• Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus.
• Strong leadership skills with a track record of building, mentoring, and retaining high-performing technical teams.
• Excellent cross-functional collaboration and communication skills; able to influence without authority and align internal and external stakeholders.

Responsibilities

• Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs, ensuring alignment with overall program goals.
• Collaborate closely with Discovery teams to ensure manufacturability and facilitate smooth transition from early research to CMC development.
• Develop scalable, robust, and reproducible processes for payload linker synthesis, enabling seamless technology transfer from development labs to GMP manufacturing.
• Build and strengthen internal capabilities by developing team expertise, infrastructure, and technologies related to payload linker process development.
• Stay current of emerging technologies and scientific advancements in ADC linker and payload chemistry to maintain competitive edge.
• Champion a strong safety culture in all laboratory activities, ensuring proper handling, containment, and risk assessment practices for highly potent compounds.
• Provide technical guidance and career development support to team members, including goal setting, performance evaluations, and skills enhancement.
• Manage external collaborations with vendors and CDMOs specializing in linker and payload synthesis and process development.
• Ensure compliance with regulatory guidelines and support filing activities for INDs, BLAs, and other regulatory submissions.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees