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

About the role

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. Scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

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.
• Demonstrate 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.
• Author 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.
• Show 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.
• 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.

Qualifications

• Ph.D. in chemistry, analytical chemistry, or organic chemistry with 0-5+ years of experience in the pharmaceutical industry; or
• M.S. in chemistry, analytical chemistry, or organic chemistry with 6+ years of experience in the pharmaceutical industry; or
• B.S. in chemistry, analytical chemistry, or organic chemistry with 12+ years of experience in the pharmaceutical industry.

• Proven experience 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.

Additional Skills/Preferences

• 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.