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

Role Summary

The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization.

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 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).
• 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 development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
• Welcome varied perspectives to create new solutions.
• Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio.

Qualifications

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

• Preferred: Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations.
• Preferred: Demonstrated ability to drive and accept change.
• Preferred: Good interpersonal skills and a sustained tendency for collaboration.
• Preferred: Demonstrated success in persuasion, influence, and negotiation.

Education

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

Additional Requirements

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