Analytical Scientist - Process Translation and Execution Lilly Medicine Foundry

Role Summary

Analytical Scientist - Process Translation and Execution at Lilly Medicine Foundry. Support production of synthetic and biologic drug substance processes, collaborate with CMC, process engineers, chemists, and production staff to deliver analytical methods and information for clinical trials and regulatory submissions.

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.
• 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.
• Coordinate 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.

Qualifications

• Basic: B.S. in chemistry, chemical engineering, biology or related field.
• Experience with analytical techniques used for the characterization of synthetic and/or biologic modalities.

Additional Preferences

• Experience with product development, including technical transfer of analytical methods into manufacturing operations.
• Demonstrated ability to drive and accept change.
• Good interpersonal skills and a sustained tendency for collaboration.
• Demonstrated success in persuasion, influence, and negotiation.
• Ability to prioritize multiple activities and manage ambiguity.
• Must possess strong communication (oral, written), organizational, and leadership skills.
• Fundamental knowledge of cGMP compliance requirements and cGMP experience.

Skills

• Analytical thinking; cross-functional collaboration; project planning; technical documentation; process development; data interpretation; communication.

Education

• B.S. in chemistry, chemical engineering, biology or related field.

Additional Requirements

• Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
• On-site presence required; 8-hour days, five days per week, with flexibility for shutdowns, weekends, overnight operations.
• 0-10% travel required.