Senior QA Specialist

Editas Medicine•Cambridge, MA

About The Position

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a 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. 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.

Requirements

Proven ability to work independently, collaborate with peers, and work effectively in a team environment, all while being highly organized.
Experience supporting early phas Quality and working with CDMOs/CTOs.
Experience with batch record review and lot release.
Working knowledge of GMP requirements for Clinical Trial Material in global markets, including understanding of regulatory guidance on gene therapy products.
Experience with biologics, protein, RNA, cell/gene therapy, and/or viral products.
Expertise working within cGMP compliance and providing GMP documentation.
Strong communication and collaboration.
Strong problem solving and critical thinking ability and accustomed to risk-based decision making.
B.S. in a scientific discipline with 4+ years experience within Quality roles in the biopharmaceutical industry.

Nice To Haves

Experience with QC and/or analytical development.
Experience managing quality systems, vendors, and supporting audit management.

Responsibilities

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.