Director, LNP/TNP Drug Product Process Development

Responsibilities

• Lead scientists to design and execute process studies to define clinical and potential commercial manufacturing process for LNPs/TNPs and other parenteral drug products.
• Mentor junior scientists to improve their scientific understanding and study design and execution capabilities.
• Lead the efforts to drive the process development and characterization of various new modalities, especially LNPs/TNP late-stage development, including assessing and mitigating process risks during scale-up through an understanding of in-process and final product critical quality attributes and critical process parameters.
• Drive collaboration with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations and work closely with stakeholders to ensure the integration of novel excipients into CMC development timeline and appropriate pathway for regulatory submission.
• Drive collaboration with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs.
• Author tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters.
• Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.
• Ensure consistency in technical deliverables and documentation across transfers.
• Cross-Functional Collaboration: Represent the product research & development organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline and key deliverables to meet the requirements for regulatory submission.
• External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
• Innovation: Initiate and drive innovation to tackle critical LNP or new modalities process performance and product quality. Actively involve and contribute to BRD and cross-functional innovation to support PRD strategy decision.
• Present scientific findings and present to internal and external stakeholders and leverage the innovations to advance Lilly portfolio.

Requirements

• Ph.D. in Chemical Engineering, or Biomedical Engineering are required with a minimum of 7 years of industry experience directly in LNP/TNP product process development from lipid nanoparticle formation to fill/finish.
• Large scale process development experience from clinical to commercialization is highly preferred.
• Extensive experience and deep knowledge with process development of lipid or targeted lipid nanoparticle formulation and manufacturing process.
• Hands-on experience in designing and optimizing manufacturing processes including nanoparticle formation, purification and fill/finish.
• Strong knowledge and experience with regulatory submissions of lipid nanoparticle-based therapies is preferred.
• Strong understanding of cGMP requirements, ICH and regulatory guidelines.