Director, 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.

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 motivated individuals who are determined to make life better for people around the world.

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.  &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 antibody‑drug conjugates within a multidisciplinary team while offering access to world‑class capabilities for pharmaceutical development.

Top candidates for this position will be expected to:

• Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization of antibody‑drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
• Demonstrate a depth of knowledge in concepts relevant to linker payload, monoclonal antibody, drug substance, and drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, authoring regulatory submissions and addressing questions from global regulatory agencies.
• Drive the implementation of technical solutions and analytical strategies to enable drug substance and drug product process design.
• Collaborate within project teams to deliver robust control strategies for drug substances and drug products and/or intermediates.
• Have experience authoring IND/CTA, BLA/NDA/MAA, and country‑specific Response to Questions (RtQ).
• Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and fit‑for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas; be able to use these techniques to bring value across the antibody‑drug conjugate portfolio.
• Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
• Responsible for introduction of new methodologies for optimization of antibody‑drug conjugate development and manufacturing.
• Plan and manage short‑term and long‑term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource…