Senior Advisor, Process Development Engineer, RNA/LNP

Lilly • Indianapolis, IN

10d • Onsite

About The Position

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non-viral vector delivery vehicles. We are seeking a highly motivated engineer with experience and/or knowledge in process development of genetic medicines to advance the portfolio from clinical to commercialization of Lilly’s genetic medicine programs This position is located at Lilly’s tech center, next to the headquarter in Indianapolis. This position seeks a candidate with hands-on experience in process development of nonviral delivery vehicles, e.g., RNA-lipid nanoparticles. This candidate would collaborate across functions at Lilly’s Boston and Indianapolis sites to advance portfolio assets. If you are interested in developing novel medicine to serve patients, you should consider joining our diverse and high-performing team.

Requirements

• Ph.D. Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field and a minimum of 2 years industry experience OR an MS in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field and a minimum of 10 yrs industry experience.
• Industry experience required includes nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development.
• Sound understanding of cGMP requirements, ICH and regulatory guidelines is a must

Nice To Haves

• Experience with development of RNA-lipid nanoparticle formulation and manufacturing process is highly preferred.
• Hands-on experience in designing and optimizing manufacturing processes, or drug delivery platforms including RNAs and LNPs is highly preferred.
• Working knowledge and experience with regulatory submissions of RNA-based therapies is preferred.

Responsibilities

• Design and execute process studies to define clinical and potential commercial manufacturing process for RNA-LNPs and other parenteral drug products.
• Lead the efforts to drive the process development of various new modalities, especially RNA-LNPs 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.
• Collaborate 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.
• Collaborate 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.
• Partner with analytical colleagues and aid in the transfer and implementation of analytical methods to CMOs of portfolio molecules for in-process testing and CROs for stability testing
• 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.
• Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
• Collaborate with early-stage stakeholders to support a strong innovation agenda for the team leading to publications, presentations and industry wide influence. Leverage these innovations to advance the Lilly portfolio.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees