Director, Analytical Chemistry - Antibody-Drug Conjugates

Eli Lilly and Company • Indianapolis, IN

5d • Onsite

About The Position

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. 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 the Director of Analytical Chemistry for linker payload of Antibody-Drug Conjugates, 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.

Requirements

• Ph.D. in analytical chemistry or organic chemistry, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15+ years (or M.S. in chemistry with 10+ years) of experience in the pharmaceutical industry.
• Proven leadership in CMC analytical development for linker-payloads/small molecule therapeutics or synthetic molecule.
• Strong expertise in analytical techniques such as HPLC, GC, IC, LC/MS, impurity profiling/structure elucidation, and method qualification/validation.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.

Nice To Haves

• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
• Strong technical skills to enable innovation which creates business value.
• Experience with analytical method development, control strategy implementation, and/or regulatory submissions related to linker-payloads or small molecule therapeutics.
• Creativity and ability to transform ideas into marketable products and processes.
• Knowledge and experience with management of a technical project.
• Demonstrated leadership capabilities especially in a team environment.
• Demonstrated ability to drive and accept change.
• Demonstrated success in persuasion, influence, and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and manage ambiguity.
• Ability to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

Responsibilities

• Lead analytical efforts focused on development and commercialization of the linker payload intermediate required for antibody-drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
• Lead external and/or lead internal analytical method development and qualification of ADC linker-payload intermediate and RSM; establish specifications, characterize impurities and degradation pathways, support purge/fate studies, establish reference standard and stability studies
• Collaborate within project teams to deliver robust control strategies for linker payload intermediates and process impurities.
• Demonstrates a depth of knowledge in concepts relevant to the linker or payload, monoclonal antibody, drug substance, and drug product commercialization, including developing analytical methods, justifying specifications, authoring regulatory submissions and addressing questions from global regulatory agencies.
• Drive the implementation of technical solutions and analytical strategies to enable linker payload intermediate and/or conjugated drug substance/drug product process design.
• 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 allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate closely with organizations across Discovery, Development, and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thoughts, backgrounds, and experiences to deliver innovative solutions.
• Possess strong communication (oral, written), organizational, and leadership skills.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly portfolio.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree