At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas is seeking an experienced and highly motivated team leader to assist in build out the Manufacturing Science & Technology group to support the transition from process characterization and clinical manufacturing to late-stage clinical and commercial manufacturing of CRISPR gene editing medicines. The successful candidate will mentor, train, and openly communicate with a team of engineers and scientists to provide advice and guidance on manufacturing technologies and processes. Including leading a Deviation Team and assessing the right tools to collect and analyze data for continuously improving manufacturing performance (CPV program).

This person is tasked with fostering a team collaboration environment in order to coordinate cross-functionally with Process and Analytical Development, Internal and External Manufacturing, Validation and Metrology, Quality Control and Analytical Technologies (QCAT), Quality Assurance, and Regulatory to support process validation and manufacturing of gene editing components and ex vivo CRISPR gene-edited cell therapies both internally and at Contract Manufacturing Organizations (CMOs). This role requires strong technical writing skills and first-hand knowledge of the industry guidance’s related to process validation, process monitoring, and technical transfer.

Key Responsibilities:

As the Associate Director, you will be responsible for:

Building and leading a team of engineers, scientists, and associates to develop technical transfer, process qualification, and continuous process verification strategies and programs for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally or at CMOs
Leading deviation writing team, reduces burden on Process Development in transition, with the goal of co-owning Process Deviations and Manufacturing Deviations in partnership with the Technical Operations team in Waltham and Devens manufacturing facilities and owning/responsibility for complex manufacturing investigations and providing technical evaluations for deviation investigations, corrective and preventative actions, and change controls
Establishing MS&T SOP’s that govern the Tech Transfer Roadmap and provide Inspection Readiness
Perform and facilitate technology transfer into the internal late stage clinical and commercial manufacturing facility and at CMOs.
Lead and initiate the guidelines for the CPV program and establish a structure to use real time manufacturing data to enhance the process, minimizing patient cell collections and delays to production.
Provide input as SME for BLA and all types of Regulatory documents including authoring, review, approval prior to submission to the Regulatory Agencies. Represent the department during audits, pre-approval inspections and provide written responses to inspections and audit observations.
Establish and maintain the Process Validation Master Plan (PVMP) for manufacturing process, aseptic process, and shipping validation, working cross-functionally with key stake holders and responsible functions to ensure the defined VMP activities are executed and maintained and all supporting documentation is complete and accurate.
Create and foster an environment of learning and information cross-functionally across the organization.
Perform a wide range of managerial duties pertaining to employees including on-the-job training and career development, identifying opportunities and provide the means for employees to pursue career growth.

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