Senior Scientist / Senior Engineer, LNP Process Development

The role

The Senior Scientist / Senior Engineer, LNP Process Development will provide technical leadership for the development, characterization, and scale-up of lipid nanoparticle (LNP) formulation and drug product manufacturing processes. This role drives LNP process development from formulation and optimization to technology transfer support for pipeline assets.

What you will do

• Lead the design, execution, and optimization of LNP processes from bench through GLP/GMP scale
• Serve as a subject matter expert for LNP process development across programs
• Evaluate and implement emerging technologies and process innovations
• Support technology transfer activities to external CDMOs
• Author and contribute to CMC sections of regulatory filings and responses
• Maintain documentation using electronic lab notebooks
• Generate experimental protocols, development reports, and SOPs
• Communicate technical information to cross-functional stakeholders and external partners

Required qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, Materials Science, or a related discipline with 8+ years of relevant industrial experience in LNP process dev
• M.S. with 12+ years of relevant industrial experience in LNP process development and formulation development
• Expertise in LNP formulation processes, TFF operations, and related characterization methods
• Hands-on experience with LNP delivery and formulation development
• Experience with process scale-up from bench to GLP/GMP scale
• Experience with technology transfer to GMP facilities and/or CDMOs
• Proficiency in analytical characterization techniques (HPLC/UPLC, DLS/SLS, TEM, DSC, SAXS, UV-Vis, fluorescence spectrophotometry)
• Experience with statistical design of experiments (DoE)
• Knowledge of Quality by Design (QbD) methodologies
• Hands-on experience with defining and setting up equipment systems for LNP and TFF processes
• Knowledge of CMC regulatory requirements
• Experience contributing to IND/CTA submissions

Benefits

• Medical
• Dental
• Vision
• Life insurance
• 401(k) match
• Equity programs
• Generous paid time off
• Wellness days
• Company-wide recharge breaks

About the company

Prime Medicine is a biotechnology company using its proprietary Prime Editing platform to develop gene editing therapies. The company focuses on therapeutic programs in hematology, immunology & oncology, liver and lung.