Senior QC Specialist, Sample Management

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 Medicine is seeking a Senior Specialist, QC Sample Management, who can support the activities related to sample management/sample submission for internal testing and testing performed at contract organizations. This person will also coordinate testing related activities and support efforts to obtain and review results. The ideal candidate will have experience with a variety of analytical testing methods including, but not limited to HPLC, UV, CE, Bioassay, PCR, Gel Electrophoresis and compendial testing. Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment.

Key Responsibilities

• Coordination of sample shipments for product release and results tracking
• Reviews QC testing data and/or Biologics analytical methods generated by vendor test labs.
• Supports vendor OOS/ATI/Investigations, verifies that data meets current specifications, generates COA(s), and tracks cycle time metrics, captures related deviations, OOS, CAPAs, atypical results, change controls.
• Assists in the planning of basic unit operations
• May communicate with vendor test laboratories.
• Works with department peers to execute well defined assignments.
• Prepares protocols/reports as appropriate/necessary
• Reviews and interprets data with support from a supervisor
• Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility
• Assists with method transfer and method validations at vendors as appropriate.
• Initiate workflows for protocol and report uploads/approvals in relevant electronic documentation systems
• Downloads data from vendor sharepoints/databases/LIMS.

Requirements

• Bachelor’s degree in Chemistry or Biology with 5+ years of Quality Control or Analytical Development experience in Biopharma.
• Analytical and problem-solving Skills. Able to troubleshoot routine issues or problems using appropriate information
• Working knowledge of GMP compliance
• 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.