Senior Director, LNP Formulation & Process Development New Cambridge, MA

MiraiBio Group at Hitachi Solutions America, Ltd.; Cambridge (MA); On-site; USD 213,000 - 281,000; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Other benefits

Job summary

Mirai Bio seeks a Senior Director of Lipid Nanoparticle (LNP) Formulation & Process Development to lead its LNP formulation, process development, and small-scale production programs. You will guide strategy across multiple payloads and act as a senior technical interface with clients and partners.

The role requires deep expertise in LNP formulation, strong leadership, and the ability to manage several concurrent programs while advancing development toward GMP transfer and larger-scale production.

Qualifications

• Ph.D. or equivalent with 12+ years in industry; MS 14+ years; BS 16+ years.
• Extensive hands-on LNP formulation and process development experience.
• Strong leadership and client-facing communication skills.

Responsibilities

• Lead LNP formulation, process development, and small-scale production.
• Define strategy and best practices for LNP development and production.
• Provide senior technical leadership and mentorship to the team.
• Interface with clients, support proposals and business development.
• Oversee non-GMP LNP production for in vitro and in vivo studies.

Skills

LNP formulation

Process development

Team leadership

Client-facing communication

Data interpretation

Education

Ph.D. in Pharmaceutical Sciences/Engineering/Biochemistry

M.S. in related field

B.S. in related field

Job description

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 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.

Leadership Profile

The ideal candidate is a hands‑on scientific and organizational leader who can move between technical problem‑solving, portfolio strategy, team leadership, operational planning, and client engagement. The Senior Director will be accountable for leading a high‑performing LNP organization and ensuring the reliable delivery of high‑quality formulations and development programs that enable partner and internal programs to advance.

ABOUT FLAGSHIP PIONEERING:

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID‑19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship atwww.flagshippioneering.com .

At Flagship, we accept impossible missions to enable bigger leaps. Ourcore values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengthswithout fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your backgroundand interest in Flagship.

The salary range for this role is $213,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Mirai Bio currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Mirai Bio's good faith estimate as of the date of publication and may be modified in the future.

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