Director, Process Engineer - Parenteral Drug Product Development

Responsibilities

• Lead talented scientists to design and execute complex process studies to define clinical and commercial manufacturing process for various parenteral drug products.
• Mentor scientists to improve their scientific understanding in study design capabilities.
• Lead the efforts to design the process development and characterization of various new modalities, especially novel drug product presentations for late-stage process development, including assessing and mitigating process risks during scale-up via a deep understanding of in-process and final product critical quality attributes and critical process parameters.
• Drive collaboration with Lilly’s internal and external key stakeholders to address 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 and technologies 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 and review 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 BRD 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 along with 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 complex new modalities process performance and product quality for various new modalities as well as new technologies. 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, Biomedical Engineering, or Pharmaceutical Sciences are highly preferred with a minimum of 7 years of industry experience directly in parenteral drug product process development from bulk drug product compounding to fill/finish.
  • Extensive experience and knowledge with process development of parenteral drug products such as peptides, ADCs, fusion proteins, mAbs and vaccines manufacturing process is required.
  • Large scale process development experience from clinical to commercialization is required.
  • Hands-on experience in designing and optimizing manufacturing processes including large scale compounding, filtration and fill/finish is required.
  • Strong knowledge and experience with regulatory submissions (INDs, NDAs and/or BLAs of parenteral drug products is required.
  • Strong understanding of cGMP requirements, ICH and regulatory guidelines is a must.