Director, Analytical Chemistry - Antibody-Drug Conjugates
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: January 3, 2026
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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. Organization Overview: 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 motivated individuals who are
determined to make life better for people around the world. The
Bioproduct Research and Development (BR&D) organization
delivers new medicines to patients through the development and
commercialization of insulins, peptides, oligonucleotides,
monoclonal antibodies, novel therapeutic proteins, and gene therapy
systems. BR&D is a multidisciplinary group with deep technical
expertise that works collaboratively with our discovery and
manufacturing colleagues. Located in Indianapolis, IN, scientists
have full access to Lilly’s deep pharmaceutical development
expertise and engineering capabilities. In this role, we are
seeking experienced, innovative, and motivated candidates to apply
their strong foundation in analytical sciences and experience in
pharmaceutical development to enable clinical trials, regulatory
submissions, and new product commercialization. This role offers
the opportunity to lead analytical development efforts focused on
delivery of linker payload intermediate and antibody-drug
conjugates within a multidisciplinary team while offering access to
word-class capabilities for pharmaceutical development. As the
Director of Analytical Chemistry for Antibody-Drug Conjugates, you
will play a pivotal role in driving innovation and ensuring
scientific excellence within Lilly's development pipeline. You will
be expected to foster interdisciplinary collaboration, leveraging
cross-functional expertise to advance both early and late-stage ADC
programs. Your leadership will influence strategic decision-making
and contribute to Lilly’s mission to transform patient outcomes
worldwide. Top candidates for this position will be expected to:
Position Responsibilities: Possesses prior experience leading
analytical efforts focused on pharmaceutical drug substance and/or
drug product development and commercialization of antibody-drug
conjugates, linker payload component development, as well as
demonstrate familiarity with applicable regulatory requirements and
emerging trends in the industry. Develop and validate analytical
methods for ADC linker-payload components and/or conjugated drug
substance/drug product; establish specifications, characterize
impurities and degradation pathways, and support comparability and
stability studies. Collaborate within project teams to deliver
robust control strategies for drug substances and drug products
and/or linker payload intermediates. Demonstrates a depth of
knowledge in concepts relevant to linker payload, monoclonal
antibody, drug substance, and drug product commercialization,
including developing analytical methods, justifying specifications,
designing stability studies, authoring regulatory submissions and
addressing questions from global regulatory agencies. Drive the
implementation of technical solutions and analytical strategies to
enable linker payload intermediate and/or conjugated drug
substance/drug product process design. Have experience authoring
IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions
(RtQ). Provide technical guidance for analytical activities
executed within the external network. Ensure methods are
technically sound, well developed and fit-for purpose. Execute
technology transfer to CRO/CMO organizations and Lilly
manufacturing sites. Demonstrate high learning agility and the
ability to understand and exploit effective scientific concepts and
methods across multiple subject areas; be able to use these
techniques to bring value across the antibody-drug conjugate
portfolio. Mentor and develop scientific staff. Ensure continued
technical and professional growth of group members, encourage
efforts towards excellence and knowledge sharing. Responsible for
introduction of new methodologies for optimization of antibody-drug
conjugate development and manufacturing. Plan and manage short-term
and long-term development activities. Develop and/or review
technical agendas and timelines for project work. Recommend
resource allocation to accomplish projects according to plans,
communicate progress and propose changes in timeline, objectives,
or direction. Collaborate closely with organizations across
Discovery, Development, and Manufacturing to execute and deliver
material and information for clinical trials and regulatory
submissions. Embrace diverse thoughts, backgrounds, and experiences
to deliver innovative solutions. Possess strong communication
(oral, written), organizational, and leadership skills. Actively
engage in the external environment and the ability to recognize and
apply external innovation across the Lilly portfolio. Basic
Qualifications: Ph.D. in analytical chemistry or bioanalytical
chemistry or organic chemistry, or a related field with 8 years of
experience in the pharmaceutical industry after earning degree or
alternatively a B.S. in chemistry with 15 years (or M.S. in
chemistry with 10 years) of experience in the pharmaceutical
industry. Proven leadership in CMC analytical development for
linker-payloads/small molecule therapeutics or therapeutic
biologics drug. Strong expertise in analytical techniques such as
HPLC, CE, GC, IC, LC/MS, impurity profiling/structure elucidation,
and method qualification/validation. Familiarity with ICH
guidelines, regulatory requirements and evolving industry trends.
Additional Skills/Preferences: Experience with technical transfer
of analytical methods into manufacturing operations. Experience
developing global regulatory strategies including authoring
regulatory submissions, responding to regulatory questions, and/or
registering products across global markets. Strong technical skills
to enable innovation which creates business value. Experience with
analytical method development, control strategy implementation,
and/or regulatory submissions related to antibody-drug conjugates.
Creativity and ability to transform ideas into marketable products
and processes. Knowledge and experience with management of a
technical project. Demonstrated leadership capabilities especially
in a team environment. Demonstrated ability to drive and accept
change. Demonstrated success in persuasion, influence, and
negotiation. Good interpersonal skills and a sustained tendency for
collaboration. Ability to prioritize multiple activities and manage
ambiguity. Ability to influence others to promote a positive work
environment. Demonstrated technical proficiency and ability to
create ideas for future work plans.? Additional Information:
Travel: 0 to 15% Potential exposure to chemicals, allergens, and
loud noises. Position Local: Indianapolis, IN; Lilly Technology
Center-North (LTC-N) 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 $148,500 -
$257,400 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
Keywords: Eli Lilly and Company, Bloomington , Director, Analytical Chemistry - Antibody-Drug Conjugates, Science, Research & Development , Indianapolis, Indiana