QC Operations Analyst - 2456

Location

Cambridge, MA | United States

Job description

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 a Quality Control Analyst to join the Quality team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible in conducting activities associated with product release testing at Editas Medicine QC laboratories.

You will be an active member of the Manufacturing Quality Operations Team, working to ensure timely testing and product disposition and cGMP compliance. We ’re looking for someone that understands “phase appropriate”, isn’t afraid to take risk, and will roll-up their sleeves and get a little dirty. If you’re interested in being part of a team capable of great achievements, this may be for you. Diversity of thoughts, experiences and backgrounds make us stronger, so ability to listen, debate and collaborate is a must. And last, but not least, we insist on having fun on this journey.

Key Responsibilities & Accountabilities:

• Expected to embrace Editas’s core values of Engagement, Teamwork, Drive, Resilience, and Accountability.
• Track testing and review data to ensure it meets current specification.
• Maintain accurate sampling and testing records and adhere to cGMP expectations.
• Ensure timely generation of COA.
• Partners with peers in manufacturing, engineering, validation, logistics, Corporate QA, and Corporate QC to ensure adherence the QMS and effective issue resolution.
• Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility.
• Author or review all data, SOP, test methods, validations, investigations, and other applicable documents, such as protocols and reports as assigned by supervisor.
• Assists with method transfer and method validations as assigned by supervisor.
• Participate in compliance related teams working towards the goal of continuous improvement of Quality Control processes.
• Perform maintenance of applicable instrument/ equipment calibration, temperature monitoring, reagent preparation, material and supply ordering and other general lab related responsibilities, as needed.
• Perform other laboratory duties as assigned.
• Perform routine/non-routine testing of in-process, DSI, final product, and raw material samples in accordance with Standard Operating Procedures, such as Visual Appearance Inspection, Flow Cytometry using BD FACS Canto, ID tests by FTIR, pH/Conductivity, Osmolality, Cell Count and Viability by Cellometer, Nucleic Acid concentration by NanoDrop, ELISA by Plate Reader, Colony count by StemVision, sickling reduction by ImageStream Analysis, HPLC/UHPLC, qPCR/ddPCR, and other applicable test methods.

Requirements

Knowledge, Skills & Capabilities:

• Working experience in a cGMP Quality Control laboratory is required.
• Experience with biologics is preferred.
• Collaborative with partners to advance the Editas mission.
• Strong knowledge of global regulations and guidelines (EU, U.S., Japan).
• Previous experience with cGMP clinical and commercial manufacturing.
• Experience working in a fast-paced and matrixed environment.
• Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.

Education & Relevant Work Experience:

• A minimum of a bachelor’s degree in microbiology or related discipline is required.
• A minimum of 5 years of working experience in Biotech or pharmaceutical QC microbiological laboratory.
• Physical & Travel Requirements (if applicable):
• On-site in Cambridge, Waltham, and the Devens Manufacturing facilities
• Ability to effectively work with remote and hybrid teams.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Physical & Travel Requirements:

• On-site in Cambridge, Waltham, and the Devens Manufacturing facilities
• Ability to effectively work with remote and hybrid teams.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

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.

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