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

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 Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.

Position 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. 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.

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.

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.

Basic Requirements
:

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field
• 8+ years’ experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides.
• Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical…