Advisor - Analytical Characterization - Lilly Medicine Foundry

Lilly•Lebanon, IN

20h•Onsite

About The Position

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 around the world 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 give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization and Position Overview: Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. In the Project Delivery Phase and Startup Phase of the project (2026 to 2028), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations. This will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry goes from design, start-up, and steady-state operations. The Advisor-Analytical Characterization role, a technical-track and lab-based position, seeks a collaborative, inclusive, and energetic scientist at the Lilly Medicine Foundry to oversee analytical characterization efforts (High Resolution MS, MS/MS interpretation, structure elucidation via 2-D NMR, etc.) supporting the production of synthetic and biologic drug substance processes. This role will collaborate with the parent Chemistry Manufacturing and Control (CMC) development organizations to understand the needs of the portfolio and analytical methods required to deliver on the control strategy of the drug substance. This position will work closely with process engineers, synthetic chemists, process analytical scientists, and production staff, and as such, will require good communication and prioritization skills. The ASAT group will consist of high-level scientists focused on the implementation of new technologies and analytical process improvements. This position involves working cross-functionally within the site and across the network to identify, develop, and employ new technological solutions to deliver the required information to the project teams. This position will be key to ensuring a strong safety culture and establishing safety, quality, and continuous improvement focused mindset within the organization.

Requirements

Ph.D. in chemistry, chemical engineering, biochemistry or a closely related STEM field.
Experience with analytical techniques used for the chemical and/or physical characterization of synthetic and/or biologic modalities.

Nice To Haves

Experience with method development, including technical transfer of analytical methods into manufacturing operations or control strategy development and working cross-functionally to solve technical challenges.
Extensive knowledge of mass spectrometry (LC-MS, GC-MS) and/or NMR spectroscopy.
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.

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 (LC, GC, NMR, MS, 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 characterization and biophysical characterization. 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.
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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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