Principal Scientist, LNP

Key Responsibilities

• Contribute to the design, development, and optimization of LNP formulations for mRNA delivery, including targeted LNP systems incorporating conjugated or functionalized lipids.
• Evaluate lipid composition, formulation parameters, and mixing conditions to optimize particle size, polydispersity, encapsulation efficiency, stability, release characteristics, and biological performance.
• Develop scalable, GMP-compatible manufacturing processes to support program advancement.
• Apply Quality by Design (QbD) principles and Design of Experiment (DoE) studies to study design and execution.
• Lead the development and optimization of analytical characterization methods (both in-house and at the external CDMO), including but not limited to DLS, fluorescence-based assays such as Ribogreen, HPLC/UPLC methods (CAD, UV, IP-RP, SEC, IEX), LC-MS, and endotoxin testing.
• Interpret analytical and stability data to establish meaningful correlations between physicochemical properties and biological function.
• Collaborate closely with platform biology teams to support in vitro and in vivo studies, prepare development reports and technical documentation, and contribute to technology transfer activities with external CDMO partners.
• Spearhead IND-enabling documentation and contribute to defining the long-term strategy for scalable LNP platform development.
• Perform other responsibilities as required based on business needs.

Required Qualifications & Experience

• Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with a minimum 4 years of relevant industry experience; or M.S. with 8+ years; or B.S. with 10+ years.
• Demonstrated in-depth expertise in LNP formulation and process development, including hands-on experience with microfluidic or scalable mixing technologies and downstream purification strategies such as TFF.
• Strong experience with analytical characterization of LNP systems and application of statistical design tools for process optimization.
• Highly organized, scientifically rigorous, and capable of independently driving projects while collaborating effectively in a multidisciplinary startup environment.
• Experience with mRNA therapeutics or nucleic acid delivery systems.
• Prior exposure to immunotherapy or cell therapy platforms preferred.
• Familiarity with regulatory expectations for CMC development and experience supporting technology transfer to external manufacturing partners preferred.
• Experience correlating formulation attributes with in vivo performance highly desirable.
  Ability to actively serve, collaborate, and develop relationships inside and outside the organization.
• Excellent written and oral communication skills.
• Strong analytical and problem-solving skills; great attention to detail and the ability to drive timely and fact-based decision making.
• Ability to function in a rapidly changing environment and handle multiple priorities.
• Demonstrated ability to partner, build trust, and cultivate positive working relationships with CDMOs.
• Experience with mRNA production and analytical quality control preferred.
• Effectively communicate changes and resolve issues with CDMOs.
• Lead and/or participate in cross functional development and manufacturing projects to ensure company objectives are met and exceeded.
• Ability to don and wear appropriate clean room attire and wear all required Personal Protective Equipment.