Senior Director, LNP Formulation & Process Development

Senior Director, LNP Formulation & Process Development

Cambridge, MA

COMPANY DESCRIPTION

Mirai Bio is a privately-held, Flagship-founded biotechnology company that is delivering genetic medicines from promise to performance. Mirai was built to solve one of the field’s central challenges: achieving precise, scalable delivery of diverse nucleic acid payloads to specific cells and tissues, particularly beyond the liver. By combining a large and growing proprietary in vivo biodistribution dataset, machine learning-guided lipid nanoparticle optimization, modular targeted particle design, and integrated translation and manufacturing capabilities, Mirai helps partners accelerate development, reduce technical risk, and pursue high-value programs making delivery a strategic advantage.

We are seeking collaborative, relentless problem solvers that share our passion for defining the future of genetic medicines together.

THE ROLE

We are 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 Senior Director will provide scientific and operational leadership across multiple programs, establish LNP development and production strategies, and build scalable, reproducible capabilities to support a growing portfolio. This individual 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 successful candidate will combine deep expertise in LNP formulation and processing with strong organizational leadership, program execution, and client-facing skills.

KEY 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 multiple 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.

PROFESSIONAL EXPERIENCE & QUALIFICATIONS

Required

• 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
  ; or B.S. with 16+ years
  .
• 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.

Preferred

• 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…