Senior Director, LNP Formulation & Process Development

The role

The Senior Director will lead the LNP formulation, process development, and small-scale production organization. This role provides scientific and operational leadership to support partner and internal research and preclinical programs.

What you will do

• Lead the LNP formulation, process development, and small-scale production function.
• Establish technical strategy and best practices for LNP formulation, process development, characterization, and production.
• Provide senior technical leadership across multiple programs.
• Serve as a senior technical interface with clients and partners.
• Support proposals, project scopes, presentations, and business development activities.
• Oversee non-GMP production of LNP formulations for in vitro, in vivo, and preclinical studies.
• Drive technical troubleshooting, process optimization, technology transfer, and continuous improvement.
• Establish workflows, documentation, and operational practices.
• Lead, mentor, and develop the LNP team.
• Collaborate cross-functionally to align LNP development and production with company objectives.

Required qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, Chemistry, Biochemistry, or related field with 12+ years of relevant industry experience
• M.S. with 14+ years of relevant industry experience
• B.S. with 16+ years of relevant industry experience
• Extensive hands-on experience in LNP formulation and process development
• Deep understanding of LNP composition, formation, purification, characterization, and the relationships between process parameters and product attributes
• Demonstrated ability to lead complex technical programs, interpret data, troubleshoot problems, and establish development strategies
• Proven experience leading and developing scientific teams and managing multiple concurrent programs and resources
• Strong written, verbal, presentation, and client-facing communication skills

Nice to have

• Experience in a CMO, CDMO, CRO, or other client-service organization
• Experience developing LNPs across multiple payloads and therapeutic applications
• Experience building or scaling LNP formulation, process development, and production capabilities
• Experience with technology transfer or transitioning development processes toward larger-scale or GMP manufacturing
• Experience supporting technical proposals, scopes of work, and business development activities

Benefits

• healthcare coverage
• annual incentive program
• retirement benefits
• broad range of other benefits

About the company

Mirai Bio is a privately-held, Flagship-founded biotechnology company delivering genetic medicines. It uses proprietary in vivo biodistribution datasets, machine learning-guided LNP optimization, and integrated manufacturing to help partners accelerate development.