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Associate Director - TS/MS Peptides

Eli Lilly, Indianapolis, Indiana, us, 46262

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divh2Associate Director, Technical Services/Manufacturing Science (TS/MS) - Peptides/h2pAt 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. Were looking for people who are determined to make life better for people around the world./ppEli Lilly and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, specializing in Peptides. In this role, you will provide critical technical leadership and scientific expertise to ensure the robust and compliant manufacturing of peptide drug substances, from process development through commercialization and life cycle management./ppstrongJob Responsibilities/strong/pulliLead and manage a team of scientists, providing technical guidance, mentorship, and performance management to achieve departmental goals./liliServe as the primary technical leader for peptide manufacturing processes, including synthesis and purification, resolving complex technical challenges and driving continuous improvement initiatives./liliOversee the transfer of new peptide processes from development to manufacturing, ensuring successful scale-up, validation, and regulatory compliance./liliDesign, execute, and interpret experiments to optimize existing peptide manufacturing processes, enhance yield, reduce cost, and improve product quality./liliAuthor and review technical reports, protocols, and regulatory submissions related to peptide manufacturing processes and product quality./liliCollaborate cross-functionally with RD, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless process execution and product delivery./liliLead investigations into manufacturing deviations, non-conformances, and out-of-specification results, implementing effective corrective and preventive actions (CAPAs)./liliStay abreast of industry best practices, emerging technologies, and regulatory requirements related to peptide manufacturing and analytical methods./liliPresent technical findings and recommendations to senior leadership and external stakeholders./li/ulpstrongBasic Qualifications/strong/pulliB.S. in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline/lili8+ years of relevant experience in manufacturing within the pharmaceutical or biotechnology industry/liliProven leadership experience, including direct supervision and mentorship of scientific and technical staff./li/ulpstrongAdditional Preferences/strong/pulliStrong understanding of cGMP regulations, ICH guidelines, and regulatory expectations for pharmaceutical manufacturing./liliDemonstrated ability to troubleshoot complex manufacturing issues and implement robust solutions./liliExcellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and concisely to diverse audiences./liliStrong analytical and problem-solving skills, with a data-driven approach to decision-making./liliAbility to work effectively in a fast-paced, dynamic, and highly collaborative environment./liliExperience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred./li/ul/div