Director, Parenteral Drug Product Process

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

Job summary

Lilly in Indianapolis seeks a highly motivated process engineer leader with extensive experience in parenteral drug product development from compounding to fill/finish. You will drive cross-functional collaboration and mentor scientists to advance clinical to commercialization programs.

Based at our tech center near headquarters, you will design and optimize manufacturing processes, lead tech transfer across sites, and partner with external CMOs to ensure quality and on-time delivery.

Qualifications

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

Responsibilities

• Lead scientists to design and execute complex process studies defining clinical and commercial manufacturing processes for parenteral products.
• Design process development and characterization of new modalities, mitigating risks during scale-up.
• Collaborate with internal/external stakeholders on tech transfer across sites and integrate novel excipients/technologies into CMC timelines for regulatory submission.
• Provide onsite technical oversight of clinical manufacturing at CMOs; review batch records and tech transfer documents.
• Ensure consistency in technical deliverables across transfers.
• Represent BRD on project teams and align timelines with regulatory requirements for submissions.
• Establish external relationships with academia and industry to adopt new process technologies.
• Drive innovation to address new modalities and technologies and present findings to stakeholders.

Skills

Process development

Scale-up

Regulatory submissions

Cross-functional leadership

Education

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

Job description

Lilly in Indianapolis seeks a highly motivated process engineer leader with extensive experience in parenteral drug product development from compounding to fill/finish. You will drive cross-functional collaboration and mentor scientists to advance clinical to commercialization programs.

Based at our tech center near headquarters, you will design and optimize manufacturing processes, lead tech transfer across sites, and partner with external CMOs to ensure quality and on-time delivery.