Senior Principal Scientist Process Translation and Execution Lilly Medicine Foundry
4 weeks ago
OverviewSenior Principal Scientist Process Translation and Execution Lilly Medicine Foundry. Join to apply for the Senior Principal Scientist Process Translation and Execution Lilly Medicine Foundry role at Eli Lilly and Company.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. We seek people who are determined to make life better for patients and communities.Key ContextLilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a pioneering center that integrates advanced manufacturing and drug development. The Foundry aims to accelerate innovation in manufacturing processes, expand capacity for clinical trial medicines, and speed Lilly medicines to clinics while reducing costs and environmental impact.ResponsibilitiesTech transfers: Lead or support the transfer of API/DS processes from Process Development into the cGMP facility. Translate process knowledge and control strategies into manufacturing documentation/procedures; author and review essential tech transfer documentation; conduct facility fit assessments and establish lab models; design and execute needed lab studies to ensure a successful process transfer into GMP production.Manufacturing campaign support: Provide on-the-floor support for critical operations and real-time technical expertise during clinical manufacturing campaigns. Daily attendance at process team meetings and, ideally, presence in the control room.Process troubleshooting and investigations: Serve as the technical lead for process deviations, quality events, and non-conformances. Perform root cause analysis and develop corrective and preventive actions (CAPAs).Data analysis and process monitoring: Analyze manufacturing data to monitor performance, identify trends, and ensure the process remains in control.Documentation: Author and review technical documents including tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports.Cross-functional collaboration: Work with development, manufacturing operations, quality assurance, and regulatory affairs to achieve project and manufacturing goals.Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.Training/mentoring: Provide training and mentoring to junior scientists, technicians, operators, and in laboratory procedures, data analysis, and PTE activities.Basic RequirementsBS or MS in Chemistry, Biology, Biochemistry, Chemical/Biological Engineering, or related disciplinesExperience: BS with 10+ years, or MS with 7+ years in Pharmaceutical Manufacturing Science and Technology (MSAT), Technical Service Manufacturing Science (TSMS), or Process Development; experience in manufacturing environments for synthetic molecule API; biologics DS is preferred.Additional Skills and PreferencesProblem-solving: Ability to analyze data, perform root cause analysis, and resolve complex technical challenges.Communication: Excellent written and verbal communication for technical reports, presentations, and cross-team collaboration.Collaboration: Successful experience in cross-functional, dynamic, and matrixed environments.Regulatory knowledge: Solid understanding of biopharmaceutical manufacturing principles and cGMP requirements.Project management: Experience leading small projects, coordinating activities, and managing timelines to meet goals.Other InformationInitial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicines Foundry in Lebanon, Indiana.Limited domestic and international travel (< 5%) may be required.Role requires ability to work in manufacturing and laboratory environments.Lilly is dedicated to equal opportunity and provides accommodations for applicants with disabilities. For accommodation requests, please use the Lilly workplace accommodation form. Lilly is 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.Compensation and BenefitsActual compensation will depend on education, experience, skills, and location. The anticipated wage is $79,500 - $171,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program (401(k), pension, medical/dental/vision, flexible spending accounts, life insurance, vacation, leave, and well-being benefits). #J-18808-Ljbffr
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