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, and quality control.

• 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

• Problem-Solving Skills: Demonstrated ability to independently troubleshoot complex analytical challenges, conduct OOS investigations, and implement effective solutions.

• Leadership & Mentorship: Proven ability to provide technical leadership, mentor junior scientists, and influence technical direction within a team or project.

• Communication Skills: Excellent written and verbal communication skills, with the ability to present complex scientific information clearly and concisely to diverse audiences.

• Collaboration: Strong interpersonal skills with a proven ability to collaborate effectively in a cross-functional team environment.

• Innovation: Demonstrated track record of identifying and implementing new analytical technologies or approaches to solve scientific problems.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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