Senior Parenteral Process Engineer – Tech Transfer Lead

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

Job summary

Lilly in Indianapolis seeks a highly skilled process engineer leader to advance parenteral drug product development from bench to commercialization. You will drive cross-functional teams, design complex process studies, and oversee tech transfer with external CMOs.

The role emphasizes cGMP compliance, regulatory readiness, and collaboration with analytical development, quality, supply chain and manufacturing to deliver robust drug products.

Qualifications

• Ph.D. in Chemical/Biomedical/Pharmaceutical Sciences with 7+ years in parenteral drug product process development.
• Experience in large-scale process development from clinical to commercialization.
• Hands-on design and optimization of manufacturing processes including fill/finish.
• Strong knowledge of regulatory submissions (INDs/NDAs/BLAs) and ICH guidelines.

Responsibilities

• Lead scientists to design and execute complex process studies for parenteral drug products and mentor teams.
• Drive process development and characterization of new modalities for late-stage development and scale-up.
• Collaborate with internal and external stakeholders to address tech transfer challenges and ensure regulatory alignment.
• Support clinical manufacturing at CMOs; author and review tech transfer documents and batch records.
• Ensure consistency in technical deliverables and documentation across transfers.
• Represent BRD on project teams and coordinate with cross-functional partners to meet regulatory timelines.
• Engage with academic and industry partners to adopt new process technologies.
• Drive innovation to improve process performance and product quality across modalities.

Skills

Process engineering leadership

Parenteral drug product development

Cross-functional collaboration

Regulatory submissions (INDs/NDAs/BLAs

Education

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

Tools

Tech transfer

cGMP compliance

Job description

Lilly in Indianapolis seeks a highly skilled process engineer leader to advance parenteral drug product development from bench to commercialization. You will drive cross-functional teams, design complex process studies, and oversee tech transfer with external CMOs.

The role emphasizes cGMP compliance, regulatory readiness, and collaboration with analytical development, quality, supply chain and manufacturing to deliver robust drug products.