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’re looking for an experienced Quality Assurance professional who can help deliver on the promise of Prime Medicine by partnering with external Contract Development and Manufacturing Organizations (CDMOs) to ensure the on-time delivery of  safe and effective products and to our early and clinical development programs. The role requires an understanding of quality requirements for advanced therapies and an ability to collaborate effectively to ensure those requirements are met. This role will also be responsible for building and developing a team of QA specialists over time to support Prime Medicine’s growing pipeline.

Responsibilities:

  • Provide Quality Assurance oversight of contract testing and manufacturing organizations, working with them to establish and meet clearly defined expectations that advance product development.
  • Serve as the Quality Assurance representative on vendor-facing CMC project teams, providing clear communication to help remove the element of surprise from supply chain operations.
  • Collaborate across functions to understand and anticipate quality needs and proactively plan for their implementation.
  • Negotiate Quality Assurance agreements with key business partners and ensure compliance with their provisions.
  • Review and approve master batch production records, protocols, reports, specifications and other documents for clarity, completeness, and compliance with Prime Medicine requirements.
  • Perform batch disposition activities, ensuring that all batch-associated records have been reviewed and documented and that any discrepancies have been satisfactorily resolved. 
  • Support and conduct (as needed) timely and risk-based audits of CDMOs and work with key external manufacturing stakeholders to maintain Prime Medicine’s Approved Supplier List
  • Ensure the adoption and ongoing maintenance of Prime Medicine’s current, approved product specifications within the relevant CDMO quality system(s).
  • Manage and continually improve the organization of vendor documents and records to facilitate their ready retrievability.
  • Collaborate with CDMO representatives on the review and approval of change controls, deviations and corrective and preventive actions.
  • As appropriate, collaborate with principal investigators or other clinical staff to provide GxP-relevant information or recommendations.

Qualifications:

  • Bachelor’s degree in science or other relevant field, additional business training or education strongly desired; cell therapy and gene editing experience highly desired
  • Experience in contract quality operations, QC, CMC or manufacturing. Experience in early clinical development programs desired; 9+ years of industry experience overall
  • Experience interpreting and applying regulations in a phase-appropriate manner
  • Excellent verbal and written communication skills to keep things simple and strong interpersonal skills to build our community of talent
  • Ability to prioritize and proficiency in using data to solve problems.

 

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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