Senior Director, ADC Process Development at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Feb, 26

Salary

228800.0

Posted On

13 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Chemistry, Leadership, Regulatory Submissions, CMC Workflow, Process Development, Tech Transfer, GMP Manufacturing, Linker-Payload Design, Conjugation Technologies, High-Potency APIs, Matrixed Environment, Collaboration, Innovation, Safety Protocols, Team Management, Strategic Oversight

Industry

Pharmaceutical Manufacturing

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: We are seeking a Senior Director, ADC Process Development, to lead and expand our growing team of scientists and engineers focused on delivering Lilly’s Antibody-Drug Conjugate (ADC) portfolio. This role will be responsible for driving the end-to-end development of small molecule payloads, linkers, and conjugation processes from preclinical through commercial. This is a high-impact role that sits at the critical intersection of chemistry, engineering, and biologics, requiring technical excellence, strategic oversight, and strong team leadership. Position Summary: The ideal candidate will bring deep expertise in small molecule process chemistry, combined with a strong track record of leadership in cross-functional and matrixed environments. This position plays a critical role in building a world-class ADC platform and advancing Lilly’s pipeline of innovative medicines. Key Responsibilities include: 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. Basic Requirements: 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. Additional Skills and Preferences: 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. 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 $156,000 - $228,800 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. #WeAreLilly

Responsibilities

The Senior Director will lead a multidisciplinary team focused on the development of Lilly’s Antibody-Drug Conjugate (ADC) portfolio. This role involves driving the end-to-end development of small molecule payloads, linkers, and conjugation processes from preclinical through commercial stages.