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Senior Associate Scientist/Scientist I, QC

Cambridge, MA

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 eighteen programs initially focused on genetic diseases with a fast, direct path to treating patients or with a high unmet need because they cannot be treated using other gene-editing approaches. Over time, the Company intends to maximize Prime Editing’s therapeutic potential and advance potentially curative therapeutic options to patients for a broad spectrum of diseases. For more information, please visit www.primemedicine.com.

Position Overview

We are currently seeking a talented and motivated Scientist to join the analytical development and QC testing team in Prime’s Technical Development and Operations Division. This individual will perform and manage QC testing, critical reagents, and stability protocols for drug substances and drug products at Prime Medicine. The Quality Control Scientist will be responsible for optimization, qualification, transfer, verification, and QC implementation of methods associated with cGMP production of cell and gene therapy drug products and gene editing components.  This individual will collaborate with Prime’s Analytical Development team and external partner representatives (CTL/CDMO) on test methods to support testing of cell and gene therapy products; writing protocols, test methods; overseeing and/or participating in execution of method lifecycle activities.  This is a hands-on role where the successful candidate will be involved in day-to-day laboratory activities. The ideal candidate will work under limited supervision and will excel in a matrixed environment, as this role will interface with the quality teams, informatics team, process development, formulation, and research teams to advance the Prime Editing therapeutic product pipeline, with a focus on later stage product candidates.  

This position offers significant opportunities for professional growth in a fast-paced biotech environment which includes moving prime editing therapeutics into clinical development and collaborating with world-class researchers.

 Key Responsibilities:

  • Perform Quality Control testing of Prime Editing drug product and drug substance samples using USP and other selected test methods. Perform data analysis, data trending, and maintain GxP compliance electronic documentation. 
  • Collaborate with process development and research groups and perform non-GMP sample testing supporting multiple programs.
  • Support test method tech-transfer, work with CTL/CDMOs providing oversight, troubleshooting as needed, and ensuring technical and timeline requirements are met.
  • Develop and qualify selected quality control tests methods for drug products, gene-editing components, and raw materials. Participate in method qualification, validation, compendial method verification, and performance monitoring.
  • Manage reference standard, critical reagents, and inventory. Assist stability data analysis and trending.
  • Work with Quality group to ensure data integrity and regulatory compliance.
  • Author and/or review protocols, SOPs, technical documents.
  • Support the installation and qualification of new QC equipment’s for implementation of methods, ensuring 21 CFR Part 11 compliance.
  • Maintain thorough electronic lab notebooks and documentation records, and present findings to multi-disciplinary teams in various oral and written formats

Qualifications

  • BS/MS in biology, Chemical Engineering, Bioengineering, or related discipline.
  • At least 5-7 years’ experience in the biotechnology or pharmaceutical industry for BS candidates, 3-5 years for MS candidates.
  • Passionate about pioneering prime editing genetic therapies and strong commitment to team and company’s success
  • Experience in assay development, qualification, and QC testing
  • Scientific knowledge in analytical methodologies including chromatography, plate-based assays, sequencing-based assays, flow cytometry-based assays, and compendial and microbial testing methods.
  • Experience in cell and gene therapies is a plus
  • Experience with qualifying and validating assays and understanding of ICH/FDA guidelines is strongly desirable
  • Experience with assessing qualification/validation requirements for assays, equipment’s, and facilities is a plus 
  • Experience in management of external CMO/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
  • Good oral and written communication skills; strong interpersonal and negotiation skills
  • 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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