Company Overview

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 replaces 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 benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview

We are currently seeking a talented and motivated Scientist/Senior Scientist with strong analytical expertise in areas of gene therapy therapeutics to join the analytical development team in Prime’s growing Technical Development and Operations group. Reporting to the head of analytical development, formulation, and QC testing, this individual will develop and apply a variety of assays for gene-editing drug substance and drug products, including nucleic acid, lipid, cellular and viral components. This is a hands-on role where the successful candidate will be involved in day-to-day laboratory activities. The ideal candidate will be highly independent and will excel in a matrixed environment, as this role will interface with the process development, pharmacology, formulation, biology, and quality teams to advance the Prime Editing therapeutic product pipeline.    

  Key Responsibilities:

  • Develop, optimize, and apply assays for the characterization and release testing of cell and gene therapy products
  • Responsible for the selection and evaluation of methodologies, and fit-for-purpose qualification/validation appropriate for the product and development stage. Generate, evaluate, communicate, and document data
  • Collaborate with Research and Process Develop groups and ensure appropriate prioritization
  • Interact with and provide oversight of external CTL (contract testing lab)/CDMO (contract development and manufacturing organizations) and support tech-transfer 
  • Proactively evaluate new technologies, stay up-to-date with current literature, and implement new features and functionalities into Prime’s analytics platform 
  • Author, review, and approve protocols, SOPs, technical documents, and analytical sections of regulatory submissions
  • Maintain thorough electronic lab notebooks and documentation records, and present findings to multi-disciplinary teams in various oral and written formats

Qualifications

  • MS/PhD in cell biology, immunology, molecular biology, or related discipline with appropriate amount of relevant experience
  • Experience in development of QC and characterization assays, including assays for LNP and AAV drug products, for the advancement of gene therapy programs 
  • Experience and expertise with purity/impurity, identity, and structural and functional characteristic testing methodologies, in-depth understanding of therapeutic components and delivery modalities
  • Experience with qualifying and validating assays and understanding of ICH/FDA guidelines is strongly desirable
  • Experience in tech transfer to and management of external CTL/CDMOs is a plus
  • Highly self-motivated and driven with a can-do, make it happen attitude and ability to own and drive projects
  • Strong collaborator with cross-functional teams and external partners
  • Ability to adapt quickly in a fast-paced environment with changing priorities
  • Highly organized and detail-oriented

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.

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