Director, Process Engineer - Parenteral Drug Product Development

Lilly Bioproduct Research and Development Process Engineer Leader

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral drug products of various modalities spanning from small molecules, peptides, oligopeptides, bioconjugates, proteins, vaccines to monoclonal antibodies, etc. The organization is also committed to the development of genetic medicines which includes active investments in AAV, LVV, mRNA, nanomedicines for tissue specific targeting and other gene delivery strategies.

The drug product team is also investing in building new technology capability to support complex drug product commercialization in different drug product presentations such as co-formulation, high concentration, and long-acting presentations, etc. in different devices as the combination products.

We are seeking a highly motivated process engineer leader with extensive industry experience and knowledge in parenteral drug product process development from compounding to fill/finish to advance Lilly portfolio from clinical to commercialization. This position is located at Lilly's tech center, next to Lilly's headquarter in Indianapolis. This position seeks a candidate with extensive industry experience in process development. This candidate would drive cross-functional collaboration with Lilly internal and external key stakeholders to advance portfolio assets.

If you are interested in developing novel medicine to serve millions and millions of patients, you should consider joining our diverse and high-performing team.

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…