Senior Director, Late-Stage RNA-LNP Process Development

Eli Lilly and Company; Boston (MA); On-site; USD 168,000 - 246,000; Full time

Job summary

Lilly is seeking a leader for Late-Stage LNP Process Development to shape the technical roadmap and drive scale-up, process characterization, and tech transfer for Phase 3 and commercialization. You will partner across stages to ensure robust, compliant manufacturing processes and strategic collaboration.

The role requires deep experience in RNA-LNP development, regulatory interactions, and the ability to influence across stakeholders while delivering state-of-the-art solutions in a fast-paced

Qualifications

• PhD with 10+ years of industry experience in pharmaceutical process development or related field.
• Proven experience with RNA-LNP process development, scale-up, and tech transfer.
• Experience creating phase-appropriate assay development, qualification, and transfer for lot release and stability.
• Strong understanding of ICH guidelines and cell/gene therapy practices.
• Excellent problem-solving skills and ability to influence scientific direction.

Responsibilities

• Establish the technical roadmap for the Late-Stage LNP Process Development team.
• Drive process development, optimization, scale-up, process characterization, and understanding for late-stage LNP Drug Product programs.
• Partner with Early-Stage LNP Process Development and Analytical Development to develop scale-up and comparability strategies.
• Develop Phase 3 ready manufacturing processes and transfer to late-stage internal and external manufacturing partners for Phase 3 and commercialization.
• Establish and execute process characterization strategies to prepare for commercial process lock.
• Define product requirements and capacity needs for Phase 3 and commercial processes and assist in site selection.
• Lead development, optimization, and pre-qualification of analytical methods; support testing programs across SP, process, formulation, and finished product.
• Drive innovative process solutions for robust production of RNA-LNP products including tLNP.
• Author and review technical reports and regulatory submission sections; participate in regulatory interactions as needed.
• Identify external collaborations to enhance capabilities and represent the company at scientific meetings.

Skills

RNA-LNP processes

Tech transfer

Assay development

ICH guidelines

Problem solving

Stakeholder influence

Parenteral products

Regulatory submissions

Statistics & data management

Education

PhD in engineering/chemistry/molecular biology or related field

Job description

Lilly is seeking a leader for Late-Stage LNP Process Development to shape the technical roadmap and drive scale-up, process characterization, and tech transfer for Phase 3 and commercialization. You will partner across stages to ensure robust, compliant manufacturing processes and strategic collaboration.

The role requires deep experience in RNA-LNP development, regulatory interactions, and the ability to influence across stakeholders while delivering state-of-the-art solutions in a fast-paced