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 35,000 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.
The Bioprocess Research and Development team has an exciting opportunity for an innovative scientist, technical expert to join our process development organization. You will be part of a diverse team of biochemists, biologists, chemical engineers, and analytical chemists to develop Lilly’s growing portfolio of therapeutic products and various modalities (AAV gene therapy products, mAb, fusion proteins, bioconjugates and etc.) at all stages of development.
The Director/Sr Director of Upstream Process Development will be responsible for drug substance process development of AAV-based gene therapy products and/or other products in Lilly’s biologics pipeline. The Director/Sr Director of Upstream Process Development is responsible for leading a team of scientists & engineers responsible for developing and improving the manufacturing processes for biologics pipeline and clinical phase programs. The successful candidate will leverage their deep knowledge of bio process development to advance the platform processes and contribute to advancing the portfolio. The successful candidate will also exhibit a strong commitment in employee development and thrive in a collaborative, scientifically stimulating, and fast-paced work environment.
Lead a team of scientists and engineers responsible for upstream process development activities (process design, optimization, characterization, scale-up, scale-down model, technology transfer, process troubleshooting) enabling a diverse biologics portfolio through early- and late-stage clinical development.
Advance upstream platform process technical strategy and capabilities for different modalities especially AAV gene therapy products; drive and define creative process improvement initiatives, lead a team to deliver innovations that advance technical capabilities, improve process yield, robustness, scalability for AAV production.
Author and review CMC documentation including CMC sections of regulatory submissions, technical reports to support filing and responses to regulatory agency questions
Serve as an upstream development subject matter expert, provide technical direction for process development, characterization, and commercialization activities to ensure a smooth and clear path to successful regulatory submissions for the portfolio.
Foster strong cross-functional collaborations within Development organizations; and effectively collaborate with other groups in Discovery and Manufacturing as well as external partners to develop products and new technologies.
Supervise, coach and mentor junior scientists, engineers.
PhD in Chemical Engineering, Bioprocess Engineering, Biology, Biochemistry, Chemistry, or related field with 8+ years of industry experience
Experience in CMC development, manufacturing and compliance requirements from early to late clinical phase programs
Subject matter expertise in upstream process development, including extensive hands-on experience with cell culture process development.
Strong understanding of industry and academic trends and innovative technologies in AAV process development
Expertise with variety of cell culture processing platforms and production systems (mammalian, insect, bacterial).
Upstream process development experience for viral vectors in an industry setting
Proven ability to work cross functionally, effectively plan and organize work activities and prioritize to meet schedules and deadlines
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