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Prime Medicine — Cambridge, Massachusetts
Company Overview: 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. 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.
Benefits
to patients. Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. 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