Director, Process Engineer - Parenteral Drug Product Development

About the Role

At Lilly, we serve an extraordinary purpose: making a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral drug products spanning small molecules, peptides, oligopeptides, bioconjugates, proteins, vaccines, monoclonal antibodies, and genetic medicines (AAV, LVV, mRNA, nanomedicines). The team is investing in new technology capabilities to support complex drug product commercialization, including co-formulation, high-concentration, and long-acting presentations in combination with devices.

We are seeking a highly motivated process engineer leader with extensive industry experience in parenteral drug product process development—from compounding to fill/finish—to advance Lilly’s portfolio from clinical to commercialization. This position is located at Lilly’s tech center in Indianapolis, adjacent to headquarters.

Responsibilities

• Lead talented scientists to design and execute complex process studies to define clinical and commercial manufacturing processes for various parenteral drug products.
• Mentor scientists to improve their scientific understanding and study design capabilities.
• Design process development and characterization for new modalities, especially novel drug product presentations for late-stage development, including assessing and mitigating process risks during scale-up via deep understanding of critical quality attributes and process parameters.
• Drive collaboration with internal and external stakeholders to address complex tech transfer challenges across sites, ensuring integration of novel excipients and technologies into CMC development timelines and regulatory submission pathways.
• Collaborate with the clinical manufacturing team to support manufacturing at internal and/or external CMOs; author and review tech transfer documents and batch records for accuracy.
• Provide onsite technical oversight of clinical manufacturing to address technical hurdles and ensure consistency in technical deliverables and documentation.
• Represent BR&D on project teams, partnering with cross-functional stakeholders (project management, analytical development, quality, device delivery, supply chain, manufacturing) to define drug product and CMC timelines and key deliverables for regulatory submissions.
• Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies and accelerate product development.
• Initiate and drive innovation to tackle complex process performance and product quality challenges for new modalities and technologies; present scientific findings to internal and external stakeholders.

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences highly preferred; minimum 7 years of industry experience in parenteral drug product process development from bulk compounding to fill/finish.
• Extensive experience with process development of parenteral drug products such as peptides, ADCs, fusion proteins, mAbs, and vaccines.
• Large-scale process development experience from clinical to commercialization.
• Hands-on experience designing and optimizing manufacturing processes, including large-scale compounding, filtration, and fill/finish.
• Strong knowledge and experience with regulatory submissions (INDs, NDAs, BLAs) for parenteral drug products.
• Strong understanding of cGMP requirements, ICH, and regulatory guidelines.

Work Environment

The role operates in a laboratory environment. Physical demands are consistent with lab work, including the ability to perform essential functions of the job. Reasonable accommodations may be made for individuals with disabilities.

Benefits

• Eligibility for a company bonus based on performance.
• Comprehensive benefits, including medical, dental, vision, and prescription drug coverage.
• 401(k) and pension plans.
• Vacation and flexible benefits (e.g., healthcare and dependent day care flexible spending accounts).
• Life insurance, death benefits, and certain time off/leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs/activities.

Pay

The anticipated wage for this position is $151,500 - $239,800, depending on education, experience, skills, and geographic location.