Director, LNP/TNP Drug Product Process Innovation

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 151,500 - 264,000; Full time

Benefits offered by this job

Company bonus

Job summary

Lilly’s BR&D organization seeks a highly motivated engineering leader to drive LNP/TNP process development from nanoparticle formation to fill/finish, advancing assets from clinical to commercialization. Location is Indianapolis tech center, with collaboration across Lilly sites and external partners.

You will mentor scientists, manage tech transfer challenges, and contribute to regulatory submissions while advancing innovative delivery platforms and ensuring QbD science across programs.

Qualifications

• Ph.D. in Chemical Engineering, or Biomedical Engineering with 7+ years in LNP/TNP process development.
• Deep knowledge of lipid or targeted lipid nanoparticle formulation and manufacturing.
• Hands-on experience in nanoparticle formation, purification and fill/finish.
• Experience with regulatory submissions of lipid nanoparticle therapies.
• Understanding of cGMP, ICH and regulatory guidelines.

Responsibilities

• Lead scientists to design and execute process studies defining clinical and potential commercial manufacturing processes for LNPs/TNPs and other parenteral products; mentor junior scientists.
• Drive process development and characterization of new modalities, especially LNPs/TNPs late-stage development; assess risks during scale-up.
• Collaborate with project management and tech transfer teams across sites and CMOs; integrate novel excipients into CMC timelines for regulatory submission.
• Provide oversight of clinical manufacturing; author tech transfer documents and review batch records.
• Ensure consistency in technical deliverables across transfers.
• Represent BRD on project teams; partner with cross-functional stakeholders to define timelines and deliverables for regulatory submission.
• Establish external relationships to adopt new process technologies; drive innovation for LNP or new modalities.

Skills

LNP process development

TNP formulation

Regulatory submissions

People leadership

Scale-up manufacturing

Education

PhD in Chemical Engineering or Biomedical Engineering

Job description

Lilly’s BR&D organization seeks a highly motivated engineering leader to drive LNP/TNP process development from nanoparticle formation to fill/finish, advancing assets from clinical to commercialization. Location is Indianapolis tech center, with collaboration across Lilly sites and external partners.

You will mentor scientists, manage tech transfer challenges, and contribute to regulatory submissions while advancing innovative delivery platforms and ensuring QbD science across programs.