Senior Principal Scientist, Analytical Chemistry - Synthetic Molecule Design and Development

Role Summary

Senior Principal Scientist, Analytical Chemistry - Synthetic Molecule Design and Development. Join a diverse team to deliver product and process insights for synthetic peptide and oligonucleotide programs, developing and implementing robust analytical methods and control strategies to enable clinical trial material delivery and build process understanding.

Responsibilities

• Collaborate with project teams to develop robust control strategies for drug substances and drug products, enable clinical programs, and author regulatory submissions.
• Drive analytical method development, justify specifications, design stability studies, establish starting material rationales, identify impurities, and coordinate the testing of drug substance /drug product quality characteristics.
• 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 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.
• Identify and implement innovative solutions to development challenges, monitor emerging trends in analytical chemistry, and maintain familiarity with applicable regulatory requirements.
• Demonstrate strong written and verbal communication skills to represent both the technical aspects and business-related implications of your work.

Qualifications

• BS or MS in Analytical Chemistry, Biochemistry, Chemistry, or a related field.
• 7+ years‚Äô experience in the pharmaceutical industry.
• Deep understanding of analytical method characterization and the associated performance attributes (e.g., linearity, precision, LOD/LOQ).
• Experience with chromatographic separations and a strong working knowledge of other techniques commonly used for the analysis of synthetic molecules (e.g., MS, NMR, FTIR, KF, ICP, DSC, TGA, XRPD).

Additional Preferences

• Familiarity with chemical process development, rationales for establishing material specifications, designing stability studies, and analytical method validation, preferably for synthetic peptides and oligonucleotides.
• Experience authoring or contributing to 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.

Additional Information

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