Senior Advisor, Biologics Drug Product Engineering

Eli Lilly and Company; Indianapolis (IN); On-site; USD 131,000 - 211,000; Full time

Job summary

Lilly in Indianapolis is seeking an Advisor or Senior Advisor, Engineering, Biologics Drug Product Development to define parenteral manufacturing processes for clinical and early commercial use, lead cross-functional tech transfer, and ensure regulatory readiness from IND to NDA.

The role requires deep knowledge of biologics, cGMP, and emerging technologies; you will mentor scientists, drive process qualification, and stay abreast of new platforms while collaborating with RA, analytical, and

Qualifications

• Knowledge and understanding of biologics parenteral product development.
• Understanding cGMP requirements, ICH and regulatory guidelines.
• Knowledge of and hands-on experience with lab automation and AI is a plus.
• Experience in advancing parenteral products from clinical to BLA/NDA regulatory submission is preferred.
• Demonstrated ability to influence internal and external stakeholders to drive decision-making.
• Sound understanding of antibody drug conjugates (ADC), antibody RNA conjugates (ARC), and other new modality manufacturing processes is preferred.
• Sound understanding of statistics and data management are essential.
• Strong oral and written communication skills are essential.

Responsibilities

• Define clinical manufacturing processes for parenteral drug products to support clinical manufacturing.
• Drive collaboration with cross-functional stakeholders to develop manufacturing process control strategies and criteria.
• Lead manufacturing related process design including study design, scale-up, and mentoring junior scientists.
• Serve as tech lead to drive tech transfer and review batch records for drug product and placebo.
• Collaborate with stakeholders to define process qualification and control strategies and address technical gaps.
• Author and review regulatory documents to support IND, BLA and NDA submissions.
• Author and review technical reports and promote knowledge sharing.
• Stay abreast of new technologies to drive evaluation and implementation across the portfolio.
• Ensure compliance with GMP and other regulations and maintain quality systems.

Skills

Biologics parenteral development

cGMP knowledge

Lab automation

AI experience

ADC/ARC knowledge

Statistics

Data management

Oral and written communication

Education

PhD with 0-3 years of experience

MS with 10+ years of experience

BS with 12+ years of experience

Job description

Lilly in Indianapolis is seeking an Advisor or Senior Advisor, Engineering, Biologics Drug Product Development to define parenteral manufacturing processes for clinical and early commercial use, lead cross-functional tech transfer, and ensure regulatory readiness from IND to NDA.

The role requires deep knowledge of biologics, cGMP, and emerging technologies; you will mentor scientists, drive process qualification, and stay abreast of new platforms while collaborating with RA, analytical, and