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Senior Director, LNP Formulation & Process Development

flagshippioneeringinc · Cambridge, MA USA · Mirai Bio
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<p><strong>COMPANY DESCRIPTION</strong></p> <p>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 <em>in vivo</em> 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.</p> <p><strong>THE ROLE</strong></p> <p>We are seeking an experienced <strong>Senior Director of Lipid Nanoparticle (LNP) Formulation & Process Development</strong> to lead the company's LNP formulation, process development, and small-scale production organization supporting partner and internal research and preclinical programs.</p> <p>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.</p> <p>The successful candidate will combine deep expertise in LNP formulation and processing with strong organizational leadership, program execution, and client-facing skills.</p> <p><strong>KEY RESPONSIBILITIES</strong></p> <ul> <li>Lead the <strong>LNP formulation, process development, and small-scale production function</strong> supporting partner and internal programs.</li> <li>Establish technical strategy and best practices for LNP formulation, process development, characterization, and production across multiple payloads and applications.</li> <li>Provide senior technical leadership across multiple programs, including development strategy, experimental planning, data review, risk mitigation, and technical recommendations.</li> <li>Serve as a senior technical interface with clients and partners and support proposals, project scopes, presentations, and business development activities.</li> <li>Oversee <strong>non-GMP production</strong> of LNP formulations for in vitro, in vivo, and preclinical studies.</li> <li>Drive technical troubleshooting, process optimization, technology transfer, and continuous improvement of LNP production for <strong>mRNA, siRNA, gene-editing components, and other nucleic acid payloads</strong>.</li> <li>Establish workflows, documentation, and operational practices that improve quality, reproducibility, efficiency, and scalability.</li> <li>Lead, mentor, and develop the LNP team while managing priorities, resources, capacity, and organizational growth.</li> <li>Collaborate cross-functionally to align LNP development and production with broader program and company objectives.</li> </ul> <p><strong>PROFESSIONAL EXPERIENCE & QUALIFICATIONS</strong></p> <p><em><strong>Required</strong></em></p> <ul> <li>Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, Chemistry, Biochemistry, or related field with <strong>12+ years of relevant industry experience</strong>; M.S. with <strong>14+ years</strong>; or B.S. with <strong>16+ years</strong>.</li> <li>Extensive hands-on experience in <strong>LNP formulation and process development</strong>.</li> <li>Deep understanding of LNP composition, formation, purification, characterization, and the relationships between process parameters and product attributes.</li> <li>Demonstrated ability to lead complex technical programs, interpret data, troubleshoot problems, and establish development strategies.</li> <li>Proven experience <strong>leading and developing scientific teams</strong> and managing multiple concurrent programs and resources.</li> <li>Strong written, verbal, presentation, and client-facing communication skills.</li> </ul> <p><em><strong>Preferred</strong></em></p> <ul> <li>Experience in a <strong>CMO, CDMO, CRO, or other client-service organization</strong>.</li> <li>Experience developing LNPs across multiple payloads and therapeutic applications.</li> <li>Experience building or scaling LNP formulation, process development, and production capabilities.</li> <li>Experience with technology transfer or transitioning development processes toward larger-scale or GMP manufacturing.</li> <li>Experience supporting technical proposals, scopes of work, and business development activities.</li> </ul> <p><em><strong>Leadership Profile</strong></em></p> <p>The ideal candidate is a <strong>hands-on scientific and organizational leader</strong> 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 an

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