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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Job Summary
Eli Lilly and Company is seeking a highly experienced and innovative Senior Principal Analytical Scientist to lead critical analytical development and support activities within our Technical Services and Manufacturing Sciences (TSMS) Lab. This role will be instrumental in advancing Eli Lilly's pipeline by providing expert analytical oversight, troubleshooting complex issues, and driving the implementation of cutting-edge analytical technologies to ensure product quality and process understanding.
Job Responsibilities
Serve as a subject matter expert in analytical science, providing strategic direction and technical leadership for complex analytical projects within the TSMS Lab.
Lead the design and development of complex LC-MS methods for the identification, quantification, and characterization of small molecules and peptides in support of API commercial manufacturing.
Independently leading deviation investigations and process optimization initiatives using analytical methodologies, especially LC/MS
Proactively identify, evaluate, and implement new analytical technologies and instrumentation to enhance capabilities, improve efficiency, and support API manufacturing
Ensure all analytical activities are conducted in accordance with cGMP, ICH, and other relevant regulatory guidelines.
Collaborate effectively with cross-functional teams including process development, manufacturing, quality control, and regulatory affairs. Mentor and provide technical guidance to junior scientists and laboratory personnel.
Critically analyze and interpret complex analytical data, generating comprehensive reports and presentations to communicate findings and recommendations to stakeholders.
Maintain meticulous laboratory notebooks, author analytical method documentation, and technical transfer documents.
Minimum Qualifications
Education: Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline with at least 10 years of relevant experience in the pharmaceutical or biotechnology industry; OR a Master's degree with at least 12 years of relevant experience; OR a Bachelor's degree with at least 15 years of relevant experience.
Technical Expertise: Extensive hands-on experience and deep theoretical understanding of a broad range of analytical techniques, including chromatography (HPLC, GC, UPLC), mass spectrometry (LC-MS/MS, GC-MS), spectroscopy (UV-Vis, FTIR, Raman), and other relevant physiochemical characterization methods.
Regulatory Knowledge: In-depth knowledge of cGMP, ICH guidelines, and other global regulatory requirements pertaining to analytical method development, validation,