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

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. 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.

About the role

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.

Responsibilities

• 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, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 3+ years of experience in the pharmaceutical industry; OR
• M.S. in Analytical Chemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 8+ years of experience in the pharmaceutical industry; OR
• B.S. in Analytical Chemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree 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 guidelines, regulatory requirements and evolving industry trends.

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 collaboration across functions.
• Strong communication (oral and written), organizational, and leadership skills.
• Ability to manage competing priorities and operate effectively in ambiguous environments.

Pay

The anticipated wage for this position is $126,000 - $204,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Company-sponsored 401(k)
• Pension
• Vacation benefits
• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Schedule

Onsite, working in Indianapolis, IN at Lilly Technology Center-North (LTC-N). Travel requirement: 0–10%.