Prime Medicine
Senior Scientist / Senior Engineer, LNP Process Development
Cambridge, MA · Senior · Full-time
Sponsorship not specified$145k-$161kDetected 9 hours ago
Process ImprovementGMPCRISPRResearchMass SpectrometryLeadershipCommunicationCollaborationProblem SolvingPublic SpeakingOrganizational Skills
About the role
- 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
- Author and contribute to Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings, briefing books, and regulatory responses related to LNP drug product
- 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
Responsibilities
- 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
- Evaluate and implement emerging technologies, novel materials, delivery and process innovations that continuously improve delivery efficiency, drug product quality, manufacturability, and cost of goods
- 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
Requirements
- 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
Compensation
- $145,000 - $161,000 USD
Equal opportunity
- Prime Medicine is proud to be an equal opportunity employer.
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