Director, Late-Stage RNA-LNP Process Development

BioSpace; Boston (MA); On-site; USD 168,000 - 246,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Vacation benefits

Job summary

Lilly is seeking a Director/Sr. Director for Late-Stage LNP Process Development in the U.S. This role partners with multiple teams to advance RNA-LNP drug products through late-stage development and into Phase 3-ready manufacturing for commercialization.

The candidate will drive process development, characterization, and analytical methods, while coordinating with Tech Transfer and Manufacturing for smooth scale-up and transfer to partners. Strong regulatory interaction experience is a plus.

Qualifications

• PhD in engineering, chemistry, molecular biology or related field.
• 10+ years of relevant industry experience.
• RNA-LNP process development, scale-up, and tech transfer experience.
• Solid understanding of ICH guidelines and cell/gene therapy best practices.
• Excellent problem-solving skills with ability to influence scientific direction.

Responsibilities

• Establish technical roadmap for Late-Stage LNP Process Development.
• Drive process development, optimization, scale-up, characterization, and understanding for late-stage programs.
• Partner with Early-Stage LNP and Analytical Development on scale-up strategy and risk mitigation.
• Develop Phase 3 ready manufacturing processes and transfer to internal/external partners.
• Define product requirements and site selection for Phase 3/commercial manufacturing.
• Lead development and qualification of analytical methods and testing programs.

Skills

RNA-LNP dev

Process leadership

Problem solving

Influence direction

Education

PhD in engineering, chemistry, or biology

Job description

Lilly is seeking a Director/Sr. Director for Late-Stage LNP Process Development in the U.S. This role partners with multiple teams to advance RNA-LNP drug products through late-stage development and into Phase 3-ready manufacturing for commercialization.

The candidate will drive process development, characterization, and analytical methods, while coordinating with Tech Transfer and Manufacturing for smooth scale-up and transfer to partners. Strong regulatory interaction experience is a plus.