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.

　　Editas is seeking an experienced and highly motivated leader to build Manufacturing Science & Technology to support late stage clinical and commercial manufacturing of CRISPR gene editing medicines. The successful candidate will build and lead a team of engineers and scientists to provide advice and guidance on manufacturing technologies, initiatives and strategy for continuously improving manufacturing performance. This leader and the team will need 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

　　Build and lead a team of engineers, scientists, and associates to develop technical transfer, process qualification, and continuous process verification strategies and programs and provide oversight for 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

　　Establish and maintain procedures, business processes and tools for technical transfer, process qualification, and continuous process verification using industry best practices and adhering to industry standards

　　Facilitate technology transfer into the internal late stage clinical and commercial manufacturing facility and at CMOs

　　Develop process control strategies based on identified critical material attributes (CMAs)and critical process parameters (CPPs) with the responsibility to identify and provide technical justification for the use of raw materials with the required CMAs to support secondary or alternative suppliers

　　Lead or support multi-disciplinary process validation teams, collaborating effectively cross-functionally to negotiate scheduling and commitment of resources outside the department required for validation projects

　　Establish and maintain the Validation Master Plan (VMP) 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

　　Provide technical support, advice and guidance on manufacturing technologies, initiatives and strategy for continuously improving manufacturing performance for late stage clinical and commercial supply

　　Responsible for complex manufacturing investigations and providing technical evaluations for deviation investigations, corrective and preventative actions, and change controls

　　Provide process knowledge and expertise to support equipment performance qualifications

　　Author, review, and provide strategic guidance, technical expertise, and process knowledge support during the preparation of regulatory filings

　　Represent the department during audits, pre-approval inspections, meetings, and teleconferences regarding process validation with regulatory agencies and provide related responses to inspections and audit observations

　　Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth

　　Other duties as required

　　Requirements

　　Knowledge, Skills & Capabilities:

　　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, 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

　　Strong technical leadership with the ability to apply sound judgement and effective decision making to drive the strategic objectives of the department and influence the broader business as a whole

　　Strong leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills with the proven ability to collaborate cross-functionally, drive direction, and influence company objectives

　　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

　　Education & Relevant Work Experience:

　　12+ years of experience in pharmaceutical manufacturing, manufacturing science & technology, technical development or Quality with 8+ years of experience in executing process validation, having led and managed process validation projects.

　　Physical & Travel Requirement:

　　Travel to support technical transfer efforts, as required.

　　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.

　　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.