Senior Analytical Scientist- Analytical Sciences and Technology 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 and in-line/on-line sing via process analytical technology (PAT) on the production floor.
• Transfer analytical methods from Product Research and Development laboratories with an emphasis on communication with other analytical scientists while making improvements on 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).
• Serve as a subject matter expert (SME) and technical mentor for team members; provide guidance on experimental design, data interpretation, and problem-solving.
• 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.
• Present technical findings and project updates clearly and effectively to the ASAT group and other cross-functional teams.
• 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, Biophysics, Biochemistry, or a closely related STEM field, with at least 8 years of experience in analytical characterization using chromatographic systems coupled with various detectors; or a M.S. with at least 5 years of relevant analytical characterization experience.
• Experience with analytical techniques, including but not limited to HPLC/UPLC, LC-MALS, LC-CAD/ELSD, LC-HRMS, CE/iCE and CE-MS, used for the chemical and/or physical characterization of oligonucleotides, bioconjugates, and biologics modalities.

Basic Requirements

• 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.

Additional Preferences

• Hands-on experience developing and validating analytical methods for bioconjugates and biologics, including method transfer into GMP manufacturing or QC operations.
• Demonstrated experience supporting pharmaceutical development, with a proven track record of transitioning analytical methods from development into manufacturing and commercial sing environments.
• Demonstrated ability to drive and embrace change in a dynamic environment.
• Good interpersonal skills and a sustained tendency for collaboration.
• Demonstrated success in persuasion, influence, and negotiation.
• Absorbable to prioritize multiple activities and manage ambiguity.
• Must possess strong communication (oral, written), organizational, and leadership skills.
• Working knowledge of cGMP compliance requirements, with direct cGMP experience.