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

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 components. In this role, you will lead the analytical development work within a cross-functional team including process chemists, formulation scientists, and engineers.

Key Responsibilities:

• Develop and validate analytical methods for ADC linker-payload components; establish specifications, characterize impurities and degradation pathways, and support comparability studies.

• Define control strategies and testing plans for linker-payloads, raw starting materials, and in-process intermediates.

• Drive implementation of analytical solutions and strategies to enable synthetic chemistry and process engineering needed to enable ADC linker-payload development and manufacturing.

• Collaborate across functions to deliver robust control strategies for drug-linker intermediates and conjugated drug substances/products.

• Provide technical oversight for analytical development work executed internally and by external partners (CROs/CMOs); ensure sound method development, characterization, and successful technology transfer.

• Demonstrate learning agility and the ability to apply scientific principles across multiple domains (e.g., organic chemistry, pharmaceutical sciences, PAT, and large molecule analytics).

• 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.

Basic Requirements:

• Ph.D. in analytical chemistry, organic chemistry, or a related field with 2+ 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 ADC linker-payloads or small molecule therapeutics.

• Strong expertise in analytical techniques such as HPLC, GC, IC, LC/MS, impurity profiling/structure elucidation, and method validation.

• Familiarity with regulatory requirements and evolving industry trends.

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Additional Preferences:

• Experience transferring analytical methods into manufa