Sr. Director, ADC Drug-Linker Synthetic Process Development

BioSpace; Indianapolis (IN); On-site; USD 159,000 - 233,200; Full time

Benefits offered by this job

401(k) and pension

Medical, dental, and vision benefits

Flexible spending accounts

Job summary

A global healthcare leader in Indianapolis is seeking a Ph.D. qualified individual to lead CMC process development for ADC programs. The successful candidate will drive innovative chemical strategies and ensure project compliance with regulatory standards. Extensive experience in the linker's design, team management, and the transition from discovery to manufacturing is essential. This full-time position offers competitive compensation ranging from $159,000 to $233,200, along with a comprehensive benefits package.

Qualifications

• 8+ years of experience in small molecule CMC development.
• Extensive expertise in linker design and payload chemistry.
• Experience in regulatory filings including IND and BLA submissions.

Responsibilities

• Lead and oversee CMC process development activities for ADC programs.
• Collaborate with Discovery teams for manufacturability.
• Manage external collaborations with vendors for synthesis.

Skills

Leadership

Synthetic organic chemistry

Collaboration

Problem-solving

Education

Ph.D. in synthetic organic chemistry or relevant discipline

B.S. or M.S. with 15+ years of equivalent experience

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview

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.

Position 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.

Basic 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.

Additional Skills/Preferences

• 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.

Additional Information

Physical Demands/Travel

The physical demands of this job are consistent with a lab and office environment.

Work Environment

This position’s work environment is in a laboratory and office environment.

To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $159,000 – $233,200.

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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