Senior Advisor, Analytical Chemistry - Antibody-Drug Conjugates Linker Payload Development BR&D

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 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 for antibody-drug conjugates within a multidisciplinary team while offering access to word-class capabilities for pharmaceutical development.

As a Senior Advisor of Analytical Chemistry for Antibody-Drug Conjugates Linker Payload Development, 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.

** Position Responsibilities*
* Top candidates for this position will be expected to:

+ Lead analytical development and commercialization efforts for the drug-linker intermediate used in antibody-drug conjugates (ADCs), including method development, qualification/validation, specification-setting, impurity/degradation characterization, reference standard management, and stability studies.

+ Author technical reports and CMC sections for regulatory submissions and respond to health authority questions on analytical and product quality topics (IND/CTA, BLA/NDA/MAA, and country-specific RtQs).

+ Collaborate with project teams to establish robust control strategies for linker-payload intermediates and process impurities, applying deep technical knowledge across linker/payload, mAb, and drug substance/product development.

+ Drive technical and analytical strategies enabling linker-payload intermediate and conjugated DS/DP process design.

+ Provide technical oversight for external analytical work, ensuring methods are scientifically sound and fit-for-purpose; lead technology transfer to CRO/CMO partners and internal Lilly sites.

+ Mentor and develop team members, fostering technical growth and knowledge sharing.

+ Introduce new analytical methodologies to advance ADC development and manufacturing.

+ Plan and manage development timelines and resourcing; communicate progress and adjust plans as needed.

+ Partner across Discovery, Development, and Manufacturing to deliver materials and data for clinical trials and regulatory filings.

+ Bring strong communication, organizational, and leadership skills, and stay engaged with external innovation relevant to the ADC portfolio.

** Basic*
* ** Qualifications*
* + Ph.D. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 3+ years of relevant experience in the pharmaceutical industry experience; or

+ M.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 8+ years of relevant experience in the pharmaceutical industry experience; or

+ B.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 12+ years of relevant pharmaceutical industry experience.

+ Proven leadership in CMC analytical development for…