Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development

Role Summary

The Senior Research Director, Analytical Chemistry, will provide technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes within the Synthetic Molecule Design and Development organization. The role supports clinical trials, regulatory submissions, and new product commercialization, leading analytical activities within a multidisciplinary project team.

Responsibilities

• Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
• Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
• Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific responses for registering products across global markets.
• Provide technical guidance for analytical activities within the external network. Ensure methods are sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
• Demonstrate learning agility and apply concepts across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, modeling and simulation).
• Mentor and develop scientific staff; support ongoing technical and professional growth and knowledge sharing.
• Plan and manage short-term and long-term development activities; develop technical agendas and timelines; allocate resources and communicate progress, proposing changes as needed.
• Collaborate with development and manufacturing organizations to deliver material and information for clinical trials and regulatory submissions.
• Welcome varied perspectives to create new solutions; engage in external environment to apply external innovation across Lilly's portfolio.

Qualifications

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field
• 8+ years’ experience in a pharmaceutical industry setting with focus on small molecules, synthetic peptides, or oligonucleotides
• Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization; experience developing, validating, and transferring analytical methods; regulatory documentation; overseeing CMO/CRO activities
• Strong communication (oral, written), organizational, and leadership skills

Skills

• Analytical method development, validation, and transfer
• Regulatory documentation and submissions
• Cross-functional collaboration and project leadership
• CRO/CMO management and technology transfer
• IND/CTA, NDA/MAA experience

Education

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field

Additional Information

• Travel: 0 to 10%
• Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)