Senior Analytical Scientist – Analytical Sciences and Technology - Lilly Medicine Foundry
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegmpsasregulatory submissionemacrorave
Job description
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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 Senior Analytical Scientist role, a technical-track and lab-based position on the Analytical Sciences and Technology (ASAT) team at the Foundry, seeks a collaborative, inclusive, and energetic scientist to support synthetic and biologic drug substance processes from process transfer through scale-up, optimization, and production. This role will collaborate with the parent Chemistry Manufacturing and Control (CMC) development organizations to understand the needs of the portfolio and identify the analytical methods and PAT tools required to deliver on the drug substance control strategy. This position will work closely with process engineers, synthetic chemists, biologics/process development scientists, 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 , including Process Analytical Technology ( PAT) 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 establishing a strong culture of safety, quality, and continuous improvement within the organization. Responsibilities: Transfer analytical methods from Product Research and Development laboratories with an emphasis on communication with other analytical scientists while refining test methods to improve robustness, accuracy, precision, and other attributes outlined by ICH guidelines. Drive implementation of technical solutions and analytical/PAT strategies at the Lilly Medicine Foundry to enable diverse drug substance production, including but not limited to synthetic molecules, bioconjugates, and biologics, leveraging traditional off-line testing in the laboratories or in-line/on-line testing via Process Analytical Technology (PAT) on the production floor. 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 synthetic and biologic drug substance . 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 . Coordinate instrumentation across projects to allow equal usage of available tools for project-specific needs. Author, review, or approve technical documents including SOPs, batch records, technology transfer reports, deviation reports, 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. Basic Requirements: B.S. in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, Biophysics, Pharmaceutical Science, or a closely related STEM field, with at least 8 years of experience in analytical characterization using chromatographic systems coupled with various detectors; or an M.S. with at least 5 years of relevant analytical characterization experience. 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: Extensive experience with analytical techniques, including but not limited to HPLC/UPLC, GC, LC-MS/LC-HRMS, and spectroscopic methods (e.g., NIR, Raman, UV/Vis, FTIR), used for the chemical and/or physical characterization o
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