Senior Director, LNP Formulation & Process Development

Mirai Bio•Cambridge, MA

About The Position

Mirai Bio is seeking an experienced Senior Director of Lipid Nanoparticle (LNP) Formulation & Process Development to lead the company’s LNP formulation, process development, and small-scale production organization supporting partner and internal research and preclinical programs. The role provides scientific and operational leadership across multiple programs, establishes development and production strategies, and builds scalable, reproducible capabilities for a growing portfolio. The Senior Director will lead and develop a team of scientists, serve as a senior technical interface with clients and partners, and collaborate closely with Analytical Development, Translational Biology, Project Management, and other functions. The position combines deep expertise in LNP formulation and processing with organizational leadership, program execution, and client-facing responsibilities. The role is accountable for leading a high-performing LNP organization and reliably delivering high-quality formulations and development programs that advance partner and internal programs.

Requirements

Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, Chemistry, Biochemistry, or a related field with 12+ years of relevant industry experience; or M.S. with 14+ years; or B.S. with 16+ years.
Extensive hands-on experience in LNP formulation and process development.
Deep understanding of LNP composition, formation, purification, and characterization, and of 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 Haves

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.

Responsibilities

Lead the LNP formulation, process development, and small-scale production function supporting partner and internal programs.
Establish technical strategy and best practices for LNP formulation, process development, characterization, and production across multiple payloads and applications.
Provide senior technical leadership across programs, including development strategy, experimental planning, data review, risk mitigation, and technical recommendations.
Serve as a senior technical interface with clients and partners, and 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 of LNP production for mRNA, siRNA, gene-editing components, and other nucleic acid payloads.
Establish workflows, documentation, and operational practices that improve quality, reproducibility, efficiency, and scalability.
Lead, mentor, and develop the LNP team while managing priorities, resources, capacity, and organizational growth.
Collaborate cross-functionally to align LNP development and production with broader program and company objectives.