Senior Scientist / Senior Engineer, LNP Process Development

Position Summary

The Senior Scientist / Senior Engineer, LNP Process Development will provide technical leadership for the development, characterization, and scale-up of robust, scalable lipid nanoparticle (LNP) formulation and drug product manufacturing processes. This individual will be responsible for driving LNP process development - spanning formulation, process optimization and characterization, scale-up, and technology transfer support for key pipeline assets.

Key Responsibilities

Technical Leadership & Process Development

• Lead the design, execution, and optimization of LNP processes to accommodate novel formulations and drug product manufacturing processes (LNP mixing and tangential flow filtration [TFF]) from bench through GLP/GMP scale, with emphasis on developing robust and scalable processes
• Serve as a subject matter expert for LNP process development across programs and therapeutic areas, partnering with Research, Platform, Hematology, and other teams to translate novel modalities into developable drug products
• Evaluate and implement emerging technologies, novel materials, delivery and process innovations that continuously improve delivery efficiency, drug product quality, manufacturability, and cost of goods
• Support technology transfer activities to external contract development and manufacturing organizations (CDMOs), including preparation of tech transfer packages, on-site execution support (Person-in-Plant), and process troubleshooting
• Author and contribute to Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings, briefing books, and regulatory responses related to LNP drug product
• Maintain impeccable documentation using electronic lab notebooks (ELNs); generate experimental protocols, development reports, technology transfer packages, SOPs, and technical reports to support clinical development
• Communicate complex technical information clearly through presentations, written reports, and everyday collaboration to diverse audiences including cross-functional stakeholders and external partners

Qualifications & Experience

• 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 development and formulation development; M.S. 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 from bench to GLP/GMP scale, 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) to support process development
• Experience with statistical design of experiments (DoE) and 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 and experience contributing to IND/CTA submissions
• Excellent communication skills, with the ability to effectively collaborate cross-functionally, prioritize activities to meet program goals, and present complex technical information to diverse audiences
• Highly self-motivated with strong organizational skills, the ability to manage competing priorities, and a hands-on approach to problem-solving

Pay and benefits

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).

Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits-including medical, dental, vision, life insurance, a 401(k) match, and equity programs-along with generous paid time off, wellness days, and company-wide recharge breaks.

Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.