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Associate Director Nanoparticle Formulation Jobs

Celcuity Inc.

... the Director, Pharmaceutical Development. You will focus on leading formulation and process ... Nano-milling and nanosuspension formulation. * Micro/nano-emulsions. * Salt formation and salt ...

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Associate Director Nanoparticle Formulation information

What does an associate director nanoparticle formulation do?

An Associate Director of Nanoparticle Formulation oversees the development and optimization of nanoparticle-based drug delivery systems and formulations. They lead teams in designing, testing, and scaling up nanoparticle products for pharmaceutical or biotech applications. This role also involves collaborating with other departments, ensuring regulatory compliance, and guiding research strategies to meet organizational objectives. Additionally, they mentor junior scientists and contribute to the scientific direction of projects.

What are the key skills and qualifications needed to thrive as an associate director nanoparticle formulation?

To excel as an Associate Director of Nanoparticle Formulation, you generally need an advanced degree (Ph.D. or MSc) in chemistry, pharmaceutical sciences, or a related field, along with experience in drug delivery and formulation development. Proficiency with analytical characterization tools (such as DLS, TEM, HPLC), formulation equipment, and regulatory documentation systems is typically required. Strong leadership, project management, and cross-functional communication skills help drive innovation and lead teams effectively. These competencies ensure the development of safe, effective nanoparticle drug products and the successful execution of complex R&D projects.

What are some common challenges faced by an associate director nanoparticle formulation, and how can they be addressed?

Associate Directors in Nanoparticle Formulation often encounter challenges such as scaling up laboratory formulations for commercial production, ensuring batch-to-batch consistency, and meeting stringent regulatory requirements. Addressing these challenges involves close collaboration with cross-functional teams, such as analytical development, process engineering, and quality assurance. Successful leaders in this role proactively implement robust process controls, maintain open communication with team members, and stay updated on regulatory trends to anticipate and resolve issues effectively.

What are popular job titles related to Associate Director Nanoparticle Formulation jobs?

For Associate Director Nanoparticle Formulation jobs, the most frequently searched job titles are:

Infographic showing various Associate Director Nanoparticle Formulation job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 68% Full Time, 28% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Senior Director, LNP Formulation & Process Development

Cambridge, MA • On-site

Mirai Bio, Inc.
See more jobs at Mirai Bio, Inc.external

Full-time

Medical, Retirement

Posted 15 days ago

Job description

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 at www.flagshippioneering.com.
At Flagship, we accept impossible missions to enable bigger leaps. Our core 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 strengths without 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 background and interest in Flagship.
Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.
#LI-TL1
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.
Privacy Notice for Applicants: When you apply for a role at Mirai Bio, Inc., a Flagship Pioneering portfolio company, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.

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