Senior Analytical Scientist – Analytical Characterization – Lilly Medicine Foundry

Responsibilities

• Drive implementation of technical solutions and analytical strategies to enable drug substance production at the Lilly Medicine Foundry leveraging traditional off-line testing in the laboratories or in-line/on-line testing via process analytical technology (PAT) on the production floor.
• Select and implement appropriate analytical techniques (e.g., LC, GC, NMR, MS, XRD, etc.) to support chemical process development - independently generating data that elucidates reaction mechanisms, characterizes kinetic behavior, and identifies process-related impurities.
• Provide technical leadership for analytical and biophysical characterization of a wide variety of molecules. Ensure methods are technically sound, well developed, and fit-for-purpose.
• Transfer analytical methods from Product Research and Development laboratories with an emphasis on communication with other analytical scientists while making improvements on test methods to improve robustness, accuracy, precision and other attributes outlined by ICH guidelines.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (chemistry, engineering, analytical sciences, data sciences, etc.).
• 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 for multiple modalities (small molecules, oligonucleotides, peptides, antibodies, antibody conjugates, and other modalities).
• Welcome varied perspectives to create new solutions.
• Cook up coordination instrumentation between different projects to allow equal usage of available tools for project specific needs.
• Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
• Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP and GMP requirements.

Requirements

• B.S. in chemistry, analytical chemistry, chemical engineering, biophysics, biochemistry or a closely related STEM field with >8 years of relevant analytical characterization experience using spectroscopy, chromatography, and other techniques, or M.S. with at >5 years of relevant analytical characterization experience.
• Experience with analytical characterization techniques (e.g., NMR, MS, IR, Raman, XRPD) used for the chemical and physical characterization of synthetic and/or biologic modalities.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.

Skills

• Experience with analytical method development including technical transfer of analytical methods into manufacturing operations or control strategy development and working cross-functionally to solve technical challenges.
• Working knowledge of chromatography (e.g., LC and GC) and other types of spectroscopy (e.g., NIR, CD, OR).
• Knowledge of various solid-state analytical techniques (e.g., XRF, PSD, thermal analysis, etc.).
• Demonstrated ability to drive and accept change.
• Good interpersonal skills and a sustained tendency for collaboration.
• Demonstrated success in persuasion, influence, and negotiation.
• Able to prioritize multiple activities and manage ambiguity.
• Strong communication (oral, written), organizational, and leadership skills.
• Fundamental knowledge of cGMP compliance requirements and cGMP experience.