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 seeking a Senior Scientist, CMC Process Development who will work with CMC leadership and also additional scientists and engineers to develop a robust, scalable cGMP manufacturing processes for prime editing ex vivo cells using non-viral delivery technologies. The scope of responsibilities ranges from setting up a process development laboratory, scale-up, tech transfer, and technical support for cGMP manufacturing. This is an exciting opportunity to work at the intersection of cell biology, cell processing, bioengineering, and clinical manufacturing to advance genetic medicine. This position offers significant opportunities for professional growth in a fast-paced biotech start-up which includes being the foundation of a growing group, collaborating with world-class researchers, and the possibility to help build the CMC group in a leadership role.

Primary Responsibilities:

  • Lead cell processing process development and scale-up with an emphasis on cell yields and viability, prime editing efficiency, process robustness, and control
  • Critically evaluate experiment data and communicate scientific findings as verbal presentations and written reports including protocols, and technical reports
  • Serve as a Subject Matter Expert (SME) during process development and technology transfer to CDMO, and partner with CDMO for cGMP manufacturing to manufacture prime edited drug products
  • Evaluate and design cryopreservation strategies
  • Identify the crucial in-process control points and develop an in-process control strategy
  • Establish drug product sampling plan and release strategy
  • Work with Analytics and Quality teams to develop drug product potency assays
  • Evaluate aseptic process simulation (APS) procedures
  • Keep meticulous experimental records in an electronic lab notebook

Basic Qualifications:

  • A PhD in biology or related discipline with ideally 5+ years of relevant experience
  • Experience with process development and statistical design of experiments (DoE) strongly preferred
  • Prior experience with automated GMP cell processing and GMP compliant analytic devices
  • Prior experience developing and writing standard operating procedures and draft batch records
  • Experience in collaborating with manufacturing operations in an GMP environment including technology transfer and technical troubleshooting
  • Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner
  • Able to work both independently and collaboratively in a fast-paced, dynamic, entrepreneurial, and team-based setting

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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