Reference Standard Scientist - Bioproduct Research and Development
Eli LillyAt 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 Overview: The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities. In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem-solving, and be motivated to work both independently and collaboratively in a dynamic environment. Job Description The Corporate Reference Standards Organization (CRSO) is responsible for all corporate reference standards used at Lilly. CRSO establishes corporate technical strategy and performs or coordinates the steps required to supply laboratories with approved reference standard materials and supporting data. Activities include specification and acquisition of source material, source batch candidate disposition, formulation and package development/execution, inventory management, order fulfilment, design of analytical testing protocols, evaluation of characterization data, creation and documentation of technical rationale for all decisions, and certification of profiles for reference standards. The result is a consistent supply of accurately defined standards that are demonstrated to be suitable for use in development and commercial global product testing applications. The Reference Standard Scientist is responsible for ensuring the technical integrity and overall compliance of Lilly reference standards and critical related materials. This includes establishing and maintaining reference standard batch replacement, manufacturing/packaging activities, inventory management, and evaluation testing. The scientist will work closely within the CRSO team and with global customers to ensure efficient and timely support of reference standard material and information deliverables. Key Responsibilities: Technical Use knowledge reference standard science, analytical testing techniques, and general analytical chemistry background to solve technical problems and issues Establish and execute reference standard technical strategy including source material selection, packaging, specifications, statistical design, and certification of property values Discern the impact of new batches prepared by a new route that differs from the previously established reference standard batch Work as a critical team member to handle, organize, and utilize complex data sets from multiple sources to enable data driven conclusions Project Management Manage the timely delivery of work associated with reference standard manufacturing, characterization, and inventory management Monitor existing batches and determines appropriate plans for resupply activities based on manufacturing or source batch acquisition complexity Participate in processes to meet global regulato…