Advisor, Analytical Chemistry - Antibody-Drug Conjugates

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** Organization Overview:*
* 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.  &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 to support the development of antibody-drug conjugates (ADCs), with a focus on 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.

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* Key Responsibilities:

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* + Develop and validate analytical methods for ADC conjugated drug substance/drug product; establish control strategy, specifications, characterize impurities and degradation pathways, and support comparability and stability studies.

+ Lead lab activities on purity/impurity method development and analytical testing to support conjugation process development.

+ As CMC analytical lead, collaborate within project teams to deliver robust control strategies for ADC drug substances and drug products and mAb intermediates.

+ 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. 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 strong technical skills, learning agility and the ability to apply scientific principles across multiple domains (e.g., large molecule analytics, pharmaceutical sciences).

+ Contribute to regulatory submissions (IND authoring, 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 with 3+ years of experience in the pharmaceutical industry; OR

+ M.S. in analytical chemistry with 8+ years of experience in the pharmaceutical industry; OR

+ B.S. in analytical chemistry with 10+ years of experience in the pharmaceutical industry.

+ Proven leadership in CMC analytical development for therapeutic biologics drug.

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

+ Familiarity with ICH guideline, regulatory requirements and evolving industry trends.

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** Additional Preferences:*
* + 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…