Laboratory Operations Specialist
$92k - $103kPrime Medicine
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 Department: Quality Assurance, GMP Systems Readiness and Validation Reports to: Laboratory Operations Lead
Position Summary The Laboratory Operations Specialist keeps Prime Medicine's laboratory instruments in working order and ready for inspection. The role manages the vendors who calibrate and maintain that equipment and owns the system that tracks it. The specialist works half time within Laboratory Operations and reports to the Laboratory Operations Lead.
Essential Duties and Responsibilities
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 Department: Quality Assurance, GMP Systems Readiness and Validation Reports to: Laboratory Operations Lead
Position Summary The Laboratory Operations Specialist keeps Prime Medicine's laboratory instruments in working order and ready for inspection. The role manages the vendors who calibrate and maintain that equipment and owns the system that tracks it. The specialist works half time within Laboratory Operations and reports to the Laboratory Operations Lead.
Essential Duties and Responsibilities
- Own the master service calendar for all laboratory instruments and equipment. Schedule every qualification, preventive maintenance, calibration, and repair visit with outside vendors. Arrange repair service with vendors to return instruments to working order.
- Carry out equipment maintenance and calibration, whether directly or through a vendor technician. Confirm that records satisfy SOP requirements and specifications, escalating to QA any deviations or excursions.
- Serve as the business owner of Qualer as the system of record for equipment and calibration. Maintain equipment records, keeping calibration certificates, maintenance logs, and service records ready for inspection at all times.
- Track the calibration and maintenance status of every instrument. Tag equipment that falls out of service or calibration due date. Periodically reconcile the physical equipment inventory against Qualer and review upcoming or overdue activities, recurring failures, and other equipment-performance trends.
- Serve as the business owner of Elemental Machines as the monitoring system of controlled temperature storage units. Monitor the system for alerts and alarms, acknowledging, communicating and investigating as required by procedure.
- Maintain vendor service contacts, scopes of work, access requirements, and performance records, and provide input into the qualification or periodic evaluation of critical calibration and maintenance vendors.
- Associate's or bachelor's degree in a life science or technical field, or equivalent hands-on laboratory experience.
- Experience maintaining equipment in a GMP-regulated laboratory.
- Working knowledge of calibration and asset management systems such as Qualer.
- Strong organizational skills and comfort managing multiple vendors and schedules at once.
Vacancy posted 3 days ago
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