- Location
- Cambridge, MA · Cambridge, Massachusetts, United States
- Department
- Process Development
- Seniority
- Senior
- Education
- PhD
- Source
- Greenhouse
Description
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. 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.
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
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.
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
