Senior Scientist / Senior Engineer, LNP Process Development

Prime Medicine•Cambridge, MA

5d•$145,000 - $177,000

About The Position

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com. Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can "search and replace" to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replace the segment of faulty DNA with a correct copy of DNA. A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations. We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefits to patients. Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease.

Requirements

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

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
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