All Of Our Groups
healthcare
Advisor/SeniorAdvisor,ProcessDevelopmentEngineer,RNA/LNP
“Advisor/Senior Advisor, Process Development Engineer, RNA/LNP at All Of Our Groups. Skills: process development of genetic medicines, RNA-LNP process development, nonviral delivery vehicles process development. 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.”
What You'll Achieve.
advance the portfolio from clinical to commercialization of Lilly’s genetic medicine programs; meet the requirements for regulatory submission
Industry & Context.
mitigating process risks; address any technical hurdles during manufacturing
What They're Looking For.
Must Have
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 Have
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.
What You'll Do.
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.
Assess and mitigate process risks during scale-up.
Collaborate with project management and other technical leaders to execute complex tech transfer challenges across sites.
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.
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 and CROs.
Represent the product research & development organization on project teams.
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 innovation agenda for the team leading to publications
presentations and industry wide influence.
How You'll Work.
Team & Collaboration
Collaborate across functions at Lilly’s Boston and Indianapolis sites.; Collaborate with project management and other technical leaders.; Collaborate with clinical manufacturing team.; Partner with analytical colleagues.; 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.; Collaborate with early-stage stakeholders.
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