Parenteral Drug Product Process Leader

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 151,500 - 239,800; Full time

Job summary

Lilly’s BRD organization seeks a highly experienced process engineer leader to drive parenteral drug product development from compounding to fill/finish, coordinating with internal and external stakeholders to advance pipeline assets at Lilly’s tech center in Indianapolis.

The role emphasizes cross-functional collaboration, risk management during scale-up, and regulatory strategy for INDs/NDAs/BLAs, with an expectation of extensive industry experience in GMP environments.

Qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, or Pharmaceutical Sciences with 7+ years in parenteral drug product process development.
• Experience with process development for parenteral products (peptides, ADCs, fusion proteins, mAbs, vaccines).
• Strong knowledge of cGMP, regulatory submissions (INDs, NDAs, BLAs) and ICH guidelines.

Responsibilities

• Lead scientists to design complex process studies for clinical and commercial parenteral drug products.
• Design process development and characterization for novel modalities and late-stage products; assess risks during scale-up.
• Collaborate with internal/external stakeholders to address tech transfer across sites and regulatory timelines.
• Provide onsite technical oversight of clinical manufacturing and ensure accuracy of batch records.
• Represent BRD on cross-functional project teams and align drug product timelines with regulatory needs.
• Establish external partnerships to adopt new process technologies and drive innovative solutions.
• Ensure consistency of technical deliverables across transfers and communications with stakeholders.

Skills

Process development

Parenteral drug products

Regulatory submissions

cGMP knowledge

Education

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

Job description

Lilly’s BRD organization seeks a highly experienced process engineer leader to drive parenteral drug product development from compounding to fill/finish, coordinating with internal and external stakeholders to advance pipeline assets at Lilly’s tech center in Indianapolis.

The role emphasizes cross-functional collaboration, risk management during scale-up, and regulatory strategy for INDs/NDAs/BLAs, with an expectation of extensive industry experience in GMP environments.