Lead Process Engineer, Parenteral Drug Product Development

BioSpace; Indianapolis (IN); On-site; USD 152,000 - 240,000; Full time

Job summary

Lilly is seeking a highly motivated process engineer leader with extensive experience in parenteral drug product process development. Based in Indianapolis, you will drive cross-functional collaboration across internal and external teams to advance portfolio assets from clinical to commercialization.

You will mentor scientists, design complex studies, ensure robust tech transfer, and uphold cGMP and regulatory standards across scale‑up and manufacturing.

Qualifications

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

Responsibilities

• Lead scientists to design and execute complex process studies to define clinical and commercial manufacturing process for various parenteral drug products; mentor scientists to improve design capabilities.
• Design the process development and characterization of new modalities, especially late-stage presentations, including assessing and mitigating process risks during scale-up via in-process and final product CQAs and CPPs.
• Drive collaboration with internal and external stakeholders to address tech transfer challenges across sites and with CMOs, ensuring integration of excipients/technologies into CMC timelines for regulatory submission.
• Provide onsite technical oversight of clinical manufacturing at internal and external CMOs; author and review tech transfer documents and batch records for accuracy.
• Ensure consistency in technical deliverables across transfers.
• Represent BRD on project teams; collaborate with project management, analytical development, quality, device delivery, supply chain, and manufacturing to define timelines and deliverables for regulatory submissions.
• Establish and leverage relationships with academic and industry partners to adopt new process technologies.
• Initiate and drive innovations to address new modalities and technologies and present findings to stakeholders.

Skills

Parenteral process development

Cross-functional leadership

Regulatory submissions

Scale-up expertise

cGMP knowledge

Education

Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences

Job description

Lilly is seeking a highly motivated process engineer leader with extensive experience in parenteral drug product process development. Based in Indianapolis, you will drive cross-functional collaboration across internal and external teams to advance portfolio assets from clinical to commercialization.

You will mentor scientists, design complex studies, ensure robust tech transfer, and uphold cGMP and regulatory standards across scale‑up and manufacturing.