Advisor/Senior Advisor, Analytical Chemistry -Antibody-Drug Conjugates

Eli Lilly and Company•Us, IN

4d•Onsite

About The Position

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—improving lives around the world by discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. Alongside our scientific innovations, we are committed to supporting communities through philanthropy and volunteerism. The Bioproduct Research and Development (BR&D) organization delivers innovative medicines through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, antibody-drug conjugates (ADCs), novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep scientific expertise that collaborates closely with discovery and manufacturing partners. Located in Indianapolis, IN, our scientists have access to world-class pharmaceutical development and engineering capabilities. In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms. Ideal candidates will possess experience across multiple analytical techniques and demonstrate an aptitude in technical problem-solving and be motivated to work both independently and collaboratively in a dynamic environment. We are seeking an experienced, innovative, and motivated CMC Analytical Chemistry Advisor or Senior Advisor to support the development of antibody-drug conjugates (ADCs), with a focus on linker-payload intermediate and/or conjugated drug substance/drug product. In this role, you will lead the analytical development work within a cross-functional team including process chemists, formulation scientists, and engineers.

Requirements

Ph.D. in analytical chemistry, organic chemistry, or a related field with 3+ years of experience in the pharmaceutical industry; OR M.S. with 8+ years, OR B.S. with 12+ years of relevant industry experience.
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 validation.
Familiarity with ICH guidelines, regulatory requirements and evolving industry trends.

Nice To Haves

Experience transferring analytical methods into manufacturing environments.
Background in global regulatory strategy, including submission authoring and product registration.
Technical innovation skills with the ability to translate concepts into a process that can be used for commercialization.
Experience managing technical projects and leading scientific teams.
Demonstrated adaptability, influence, and collaboration across functions.
Strong communication (oral and written), organizational, and leadership skills.
Ability to manage competing priorities and operate effectively in ambiguous environments.

Responsibilities

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.
Lead lab activities on method development and analytical testing to support process development of linker-payload component and/or conjugated mAb.
Collaborate within project teams to deliver robust control strategies for drug substances and drug products and/or linker payload intermediates.
Drive implementation of analytical solutions and strategies to enable synthetic chemistry and process engineering needed to enable ADC linker-payload development and manufacturing
Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and drug product development of antibody-drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
Provides technical oversight for analytical development work executed internally and by external partners (CROs/CMOs); ensures sound method development, characterization, and successful technology transfer.
Demonstrate strong technical skills, learning agility and the ability to apply scientific principles across multiple domains (e.g., organic chemistry and/or large molecule analytics pharmaceutical sciences, PAT).
Contribute to regulatory submissions (CTD authoring, NDA/BLA filings), support pre-approval inspections (PAI), and respond to regulatory agency questions (RtQs).
Mentor and develop scientific staff; support continued professional growth, knowledge sharing, and technical excellence.
Plan and manage both short- and long-term development activities; define project timelines, allocate resources, monitor progress, and adjust plans as needed.
Partner with development and manufacturing teams to provide clinical and regulatory deliverables.
Promote an inclusive culture by embracing diverse perspectives and encouraging innovation.
Engage externally to identify and apply relevant advances in analytical chemistry and drug development.

Benefits

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).

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume