Editas Medicine

Senior QA Specialist

Cambridge, Massachusetts, United States · Senior

Sponsorship not specified$110k-$120kDetected 5 days ago

Vendor ManagementGMPFDA RegulatoryCRISPRAnimal StudiesCommunicationCollaborationProblem SolvingCritical Thinking

About the role

This role is part of a small QA team with opportunities for cross training into other areas of Quality.

Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Maintain Quality oversight of GMP operations including batch record review, analytical results, certificates of analysis, and Quality Events (e.g. deviations and change controls).
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.
Establish, implement, maintain, improve, monitor, and report on quality and compliance systems.
We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
To thrive in this role, you'll need: Proven ability to work independently, collaborate with peers, and work effectively in a team environment, all while being highly organized.

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.
Experience with batch record review and lot release.
Experience with biologics, protein, RNA, cell/gene therapy, and/or viral products.
Fundamentals That Set You Apart Experience with QC and/or analytical development.

$110,000 - $120,000 Pay Transparency Editas Medicine is committed to transparency and accuracy in our hiring practices.
The anticipated salary range for each position is posted within the role.
The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience.
Editas Medicine's compensation philosophy ensures fair and equitable pay practices.

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.
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.

This listing is sourced directly from Editas Medicine's careers page and normalized into a canonical job model.