Senior Director, Parenteral Process Engineering

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 152,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Paid time off

Job summary

Lilly’s BRD organization seeks a process engineer leader to drive parenteral drug product development from bench to commercialization at the Indianapolis tech center. You will lead teams, mentor scientists, and coordinate cross-functional activities across CMC, quality, analytical development and manufacturing to enable smooth tech transfer and regulatory submissions.

The role emphasizes scale-up, device/formulation integration, and collaboration with internal and external CMOs to accelerate

Qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences are highly preferred with a minimum of 7 years of industry experience in parenteral drug product process development from bulk drug product to fill/finish.
• Extensive experience with parenteral drug product processes including peptides, ADCs, fusion proteins, mAbs and vaccines.
• Large scale process development experience from clinical to commercialization and hands-on design/optimization of manufacturing processes.

Responsibilities

• Lead scientists to design and execute complex process studies to define clinical and commercial manufacturing processes for parenteral drug products.
• Mentor scientists to improve their study design capabilities.
• Drive design and characterization of process development for new modalities and late-stage products, assessing risks during scale-up.
• Collaborate with internal/external stakeholders to address tech transfer across sites and ensure regulatory timelines.
• Provide onsite technical oversight of clinical manufacturing and ensure consistency across transfers.

Skills

Team leadership

Project management

Process development

Regulatory submissions

Cross-functional collaboration

Education

Ph.D. in Chemical/Biomedical/Pharmaceutical Sciences

Job description

Lilly’s BRD organization seeks a process engineer leader to drive parenteral drug product development from bench to commercialization at the Indianapolis tech center. You will lead teams, mentor scientists, and coordinate cross-functional activities across CMC, quality, analytical development and manufacturing to enable smooth tech transfer and regulatory submissions.

The role emphasizes scale-up, device/formulation integration, and collaboration with internal and external CMOs to accelerate