Director - Analytical Chemistry

About the role

The Synthetic Molecule Design and Development (SMDD) organization at Lilly is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. SMDD scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates (ADCs), and other emerging therapeutic modalities. This role offers access to world-class capabilities for pharmaceutical development and requires a balance of deep technical expertise with people leadership.

Responsibilities

• Exhibit a depth of knowledge in concepts relevant to drug substance or drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, establishing starting material rationales for synthetic processes, identifying impurities, and testing drug product performance characteristics (e.g., dissolution/disintegration).
• Drive hands-on implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
• Collaborate within project teams to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
• Have experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.
• 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 (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).
• Directly manage, mentor, and develop a small team of analytical scientists (typically 2-4 direct reports). Ensure continued technical and professional growth of team members, encourage efforts towards excellence and knowledge sharing, and provide day-to-day technical guidance on analytical projects.
• 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.
• Excel in communication, leadership, and collaboration—embracing diverse perspectives to drive innovative solutions across multidisciplinary teams.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.

Qualifications

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with >8 years of experience in the pharmaceutical industry after earning degree.
• Project/technical leadership experience within an innovator organization focused on pharmaceutical product development and commercialization with specific focus on small molecules, synthetic peptides, oligonucleotides, and/or the payload-linker elements of ADCs, ARCs, etc.
• Demonstrated familiarity with applicable regulatory requirements and emerging trends in the industry.