Senior QA Specialist

Editas Medicine Senior Qa Specialist

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas
12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

At Editas Medicine, we're a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what's possible in medicine, come join us and become an Editor!

The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic to establish human proof of concept by ensuring compliance with FDA, cGMP, and international regulatory requirements across manufacturing, testing, product disposition, and quality event management. This role is part of a small QA team with opportunities for cross training into other areas of Quality.

EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.

As the Senior QA Specialist, you will:

• Maintain quality oversight of GMP operations including batch record review, analytical results, certificates of analysis, and Quality Events (e.g. deviations and change controls).
• Disposition lots.
• Provide quality review of assay validation, test method development, and other technical documents.
• Collaborate with, oversee, and support partner CDMOs/CTOs.
• Develop comprehensive understanding of the manufacturing processes for Editas products and the associated risk management control strategy to identify process risks and critical controls around processing steps.
• Author, review, and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, specifications, and summary reports) supporting GMP manufacturing.
• Establish, implement, maintain, improve, monitor, and report on quality and compliance systems.
• Assist in Quality System and Vendor Management activities