Associate Director, MS&T

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.

Requirements

Required Qualifications:

The ideal candidate will possess:

• Bachelor’s degree in a relevant scientific field with 8+ years of experience in pharmaceutical manufacturing, manufacturing science & technology, technical development or Quality with 5+ years of experience in executing process validation, having led and managed process validation projects.
• Expertise with biologics cGMP manufacturing, with experience in cell and gene therapy preferred.
• Demonstrated experience in execution of process validation programs from master plans through protocols and authoring reports.
• Experience participating in BLA preparation and pre-approval inspections preferred.
• Thorough understanding of industry guidance’s, knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.
• Experience in leading a team of direct reports and providing guidance and mentorship to junior engineers or scientists.

Preferred Qualifications:

Additionally, candidates with the following attributes are preferred:

• Expertise with biologics cGMP manufacturing, with experience in cell and gene therapy preferred.
• Strong technical leadership with the ability to apply sound judgement to drive the strategic objectives of the department and organizational goals and objectives.
• Strong leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills with the proven ability to collaborate cross-functionally and influence direction of projects from clinical to commercial manufacturing.
• Attention to detail, strong organizational skills, and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.
• Ability to drive process validation and group performance within defined timelines and manage multiple projects and resources.
• Must be well organized, flexible and work with minimal supervision and willing to directly perform tasks, as required.

Benefits

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

Fostering Belonging. Fueling Innovation. Transforming Lives.