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Senior Scientist / Senior Engineer, LNP Process Development

Prime Medicine· Process Development
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Cambridge, MA$145k - $161kFull-timePosted 3mo ago

About the role

Senior-level role providing technical leadership for development, characterization, and scale-up of lipid nanoparticle (LNP) formulation and drug product manufacturing processes, spanning formulation, process optimization, scale-up, tech transfer, and regulatory support.

Responsibilities

  • Lead the design, execution, and optimization of LNP processes from bench to GLP/GMP scale, including LNP mixing and tangential flow filtration (TFF).
  • Serve as a subject matter expert for LNP process development across programs and therapeutic areas, collaborating with Research, Platform, Hematology, and other teams.
  • Evaluate and implement emerging technologies, materials, and process innovations to improve delivery efficiency, product quality, manufacturability, and cost of goods.
  • Support technology transfer activities to external CDMOs, including tech transfer packages, on-site execution, and troubleshooting.
  • Author and contribute to CMC sections of regulatory filings, briefing books, and regulatory responses related to LNP drug product.
  • Maintain meticulous documentation using ELNs; generate protocols, development reports, tech transfer packages, SOPs, and technical reports.
  • Communicate complex technical information clearly to cross-functional teams and external partners.

Qualifications

  • Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, Materials Science, or related field with 8+ years of relevant industrial experience in LNP process development and formulation development; MS with 12+ years.
  • Demonstrated expertise in LNP formulation processes, TFF operations, and related characterization methods.
  • Hands-on experience with LNP delivery and formulation development, process scale-up to GLP/GMP, and technology transfer to GMP facilities and/or CDMOs.
  • Strong proficiency in analytical characterization techniques (HPLC/UPLC, DLS/SLS, TEM, DSC, SAXS, UV-Vis, fluorescence spectrophotometry).
  • Experience with DoE and knowledge of QbD methodologies.
  • Hands-on experience with defining and setting up equipment systems for LNP and TFF processes.
  • Knowledge of CMC regulatory requirements and experience contributing to IND/CTA submissions.
  • Excellent communication and cross-functional collaboration skills; ability to present complex technical information to diverse audiences.
  • Self-motivated with strong organizational skills and problem-solving abilities.

Skills

Required:LNP formulation developmentTangential flow filtration (TFF)Analytical characterizationDoE / QbD

Benefits

  • Total Rewards package including medical, dental, vision, life insurance; 401(k) match; equity programs; generous paid time off; wellness days; company-wide recharge breaks.
Last updated Jul 29, 2026. Interested? Apply on the company site.

About Prime Medicine

Delivering on the promise of Prime Editing

Prime Medicine™ was founded with a goal of transforming the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology.

next- generation gene editingPrime Editinggene editingtherapeutic applications
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