Editas Medicine, Inc. Cambridge , MA 02138
Location Cambridge, MA.
Editas is seeking Associate Director/Director within the Technical Development and Manufacturing team to lead the Quality Control function and support Editas' engineered cell and viral vector products that incorporate CRISPR gene-editing technologies. Reporting to the Head of Quality, the qualified candidate will be responsible for overseeing Quality Control activities at the company's Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs), as well as developing an internal QC analytical laboratory.
This position's responsibilities include but are not limited to: overseeing all internal and external quality control activities including testing and releases of raw materials, intermediates and APIs, supporting IND enabling and GMP production activities, executing proper life-cycle management of analytical methods (i.e. validation, transfer, review, approval, changes), leading OOS/OOT investigations, manage stability programs and ensure compliance to the applicable compendial and regulatory requirements. The AD/Director of QC also ensures compliance of the analytical laboratories and operations to the most current data integrity requirements, drives continuous improvement and implementation of industry best practices to maximize efficiency.