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

Overview

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 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 are 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 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.

The Senior Research Advisor, 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.

• Develop analytical methods, justify specifications, design stability studies, establish starting material rationales, identify impurities, and test drug product performance characteristics.
• Collaborate with project teams to develop robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions), enable clinical programs, and author regulatory submissions.
• Support internal process development efforts through hands-on laboratory research in a fast-paced development environment, including experimental design, sample analysis, instrument troubleshooting, and data interpretation.
• 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 external organizations and Lilly manufacturing sites.
• Plan and handle 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.
• Identify and implement innovative solutions to development challenges, monitor emerging trends in analytical chemistry, and maintain familiarity with applicable regulatory requirements.

• Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, or a closely related scientific discipline.
• 3+ years of industry experience in analytical development within the pharmaceutical or biotechnology sector, including experience supporting clinical-stage programs.
• Deep fundamental understanding of and experience with multiple forms of chromatography and mass spectrometry, as well as a strong working knowledge of other techniques commonly used for the analysis of synthetic molecules (e.g., NMR, FTIR, KF, ICP, DSC, TGA, XRPD).
• Demonstrated experience in method development, validation, and transfer for oligonucleotides, peptides, or small molecules.

• Experience authoring regulatory documentation (e.g., IND/CTAs, NDA/MAAs) and overseeing CMO/CRO activities.
• Demonstration of scientific leadership and the ability to influence others.
• Ability to prioritize multiple responsibilities, influence others, and thrive in ambiguity.

Travel: 0 to 10%

Position Location:

On-site, Indianapolis, IN;
Lilly Technology Center-North (LTC-N).

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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