--- title: 'Senior Quality Engineering Specialist at Prime Medicine' canonical: 'https://feeny.ai/job/senior-quality-engineering-specialist-prime-medicine-cambridge-yearqxvgjzt1' type: 'job' last_seen: '2026-09-09' --- # Senior Quality Engineering Specialist at Prime Medicine - **Company:** Prime Medicine - **Location:** Cambridge, MA - **Compensation:** $111k–$123k - **Posted:** 2026-09-07 - **Last confirmed live:** 2026-09-09 - **Apply:** https://job-boards.greenhouse.io/primemedicine/jobs/6184175004 ## Job 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](http://www.primemedicine.com/). 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](http://www.primemedicine.com/). ## About the role Department: Quality Assurance Reports to: VP, Quality Assurance Location: Cambridge, MA Position Summary The Senior Quality Engineering Specialist provides hands-on operational support for Prime Medicine’s GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. Working with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors, the Specialist executes qualification activities, maintains accurate records, coordinates scheduled work, and helps keep systems and equipment compliant and inspection-ready. The role also conducts risk-based assessments of software vendors in accordance with current FDA guidance, as well as assessments of equipment and material suppliers and service providers, to ensure the quality and reliability of externally supplied inputs. ## Key Responsibilities Software Assurance and Vendor Assessments - Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation. - Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations. - Conduct and document risk-based assessments of software, equipment, material, and service providers. - Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence. - Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions. Equipment Qualification and Maintenance - Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities. - Review executed protocols, reports, raw data, test results, certificates, and supporting records for completeness, accuracy, and consistency. - Support the documentation and investigation of equipment qualification discrepancies. - Maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system. - Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring that documentation is complete and properly linked to the applicable equipment. - Oversee scheduled calibration, maintenance, and service activities with equipment owners and external providers, escalating delays and compliance risks promptly. Supplier Quality and Quality Systems Support - Conduct supplier audits and remote assessments under the direction of Supplier Quality leadership. - Prepare assessment plans, document requests, questionnaires, reports, and follow-up actions. - Track vendor corrective actions and other assigned quality actions through closure. - Support change controls, deviations, CAPAs, and other quality records involving software, equipment, calibration, maintenance, or vendors. - Maintain trackers, dashboards, and status reports for qualification activities, calibration and maintenance schedules, vendor assessments, and open actions. - Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement. - Participate in audits, regulatory inspections, and inspection-readiness activities as needed. ## Qualifications - Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience. - At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function. - Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements. - Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records. - Experience using a computerized maintenance management, calibration management, or equipment tracking system. - Strong technical writing, organization, and cross-functional coordination skills. - Ability to manage multiple operational priorities, maintain accurate records, and escalate risks or delays promptly. ## Preferred Experience - Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment. - Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices. - Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records. 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. U.S. Pay Range $111,000—$123,000 USD 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. ## About Prime Medicine ## Company Overview - **One-liner**: Prime Medicine is a biotechnology company using prime editing, a next-generation gene editing technology, to “search and replace” disease-causing genetic mutations and restore normal gene function. - **Entity Type**: Public (NASDAQ: PRME, IPO October 2022) - **Headquarters**: Cambridge, Massachusetts, United States - **Founded**: 2019 - **Founders**: David Liu, PhD (Scientific Founder); Andrew Anzalone, MD, PhD (Co-founder) ## Core Business - **Primary industry**: Biotechnology / Gene Editing Therapeutics - **Target customers**: Patients with genetic diseases; partners include pharmaceutical companies (e.g., Bristol Myers Squibb) and foundations (e.g., Cystic Fibrosis Foundation) - **Mission**: “To bring the promise of gene editing to patients” and ultimately “cure, halt, and prevent genetic diseases, providing lifelong benefit to patients.” ## Products & Services - **Prime Editing Platform**: A proprietary gene editing technology that acts like a “DNA word processor” to precisely replace faulty DNA sequences without causing double-strand breaks. Designed to address ~90% of known disease-causing mutations. - **PM359** (Phase 1/2): Ex vivo prime editing therapy for p47phox Chronic Granulomatous Disease (CGD). Received FDA RMAT designation and orphan drug designation. - **PM577a** (Phase 1/2): In vivo prime editing therapy for H1069Q-mutated Wilson Disease. Clinical trial application cleared in New Zealand. - **Alpha-1 Antitrypsin Deficiency (AATD)**: Discovery-stage liver program using LNP delivery. - **Cystic Fibrosis**: Discovery program supported by Cystic Fibrosis Foundation (up to $15M), using PASSIGE™ technology. - **Ex vivo CAR-T** (collaboration with Bristol Myers Squibb): Strategic license and broad collaboration to develop and commercialize ex vivo T-cell prime editor products. ## Market Standing - **Valuation/Market Cap**: $777.8 million (as of mid-2026, per LinkedIn data) - **Key Metric**: Annual revenue $4.6 million; total funding raised ~$1.02 billion (including post-IPO equity) - **Notable Investors/Partners**: ARCH Venture Partners, F-Prime, Bristol-Myers Squibb (corporate round $55M in 2024), Google Ventures (post-IPO equity $5M in 2025), Cystic Fibrosis Foundation - **Growth Signals**: - Clinical data for PM359 published in *The New England Journal of Medicine*; RMAT designation from FDA. - Headcount of 154 (down 29.4% YoY, likely reflecting strategic refocusing). - Active job postings: 7 (as of mid-2026), with recent uptick in quarterly postings (+40%). ## Competitive Advantages - **Prime Editing differentiation**: Unlike CRISPR, prime editing does not require double-strand DNA breaks, enabling more precise and predictable edits with fewer unwanted modifications. - **Broad applicability**: Can theoretically correct ~90% of known disease-causing mutations across many organs and cell types. - **Strong IP and scientific foundation**: Co-invented by David Liu (Broad Institute), a pioneer in gene editing. ## Strategic Focus - **Advancing lead programs** (PM359 for CGD, PM577a for Wilson Disease) through clinical development and regulatory approvals. - **Expanding pipeline** in liver, lung, hematology/immunology/oncology via internal research and strategic partnerships (e.g., BMS for CAR-T). - **Leveraging delivery technologies** (LNP, AAV, ex vivo electroporation) to enable both in vivo and ex vivo applications. ## Why Work Here - **Mission-driven culture**: Opportunity to shape the future of gene editing and directly impact patients with genetic diseases. - **Collaborative environment**: Emphasis on diversity of viewpoints, scientific curiosity, and passion for patient outcomes. - **Location**: Headquarters in Cambridge, MA – a hub for biotech innovation. Presence also in India. - **Career development**: Roles span research, clinical, technical development, finance, HR, and informatics. Recent job postings include AI & Informatics Engineer, Senior Scientist, and Director of People & Culture. - **Perks & culture**: Not explicitly detailed, but the company values “dedicated, scientifically curious individuals” and offers the chance to work with a world-class scientific team. ## Sources 1. [primemedicine.com](https://primemedicine.com/) 2. [primemedicine.com/about/](https://primemedicine.com/about/) 3. [primemedicine.com/careers/](https://primemedicine.com/careers/) 4. [primemedicine.com/pipeline/](https://primemedicine.com/pipeline/) 5. [linkedin.com/company/prime-medicine](https://www.linkedin.com/company/prime-medicine) ## Other roles at Prime Medicine - [Informatics Engineer](https://feeny.ai/job/informatics-engineer-prime-medicine-cambridge-t211ebww167m) — Cambridge, MA - [Senior Scientist / Senior Engineer, LNP Process Development](https://feeny.ai/job/senior-scientist-senior-engineer-lnp-process-development-prime-medicine-h2ma4d77ffav) — Cambridge, MA - [Senior Scientist, mRNA Design & Platform Innovation](https://feeny.ai/job/senior-scientist-mrna-design-platform-innovation-prime-medicine-cambridge-hma82924aerh) — Cambridge, MA - [Senior Director, Biometrics](https://feeny.ai/job/senior-director-biometrics-prime-medicine-cambridge-5b24s6r19ew4) — Cambridge, MA