Supervisor, Quality Control Operations

4 weeks ago

Cambridge, United States Editas Medicine Full time

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. Key Responsibilities: As the Supervisor of QC Ops you will be responsible for: Support qualification and maintenance of new and existing laboratory equipment. Ensures the readiness of the QC team for all external and internal audits/inspections. Develop, revise and review SOPs, test methods, qualification/validation protocols and reports. Lead tech transfer sub teams for assay qualification and validation of molecular and cell- based assays. GMP lab for successful assay establishment and transfers and ensuring the training, protocols, data analysis, reagents, strategy and documentation are defined as needed. Work with counterparts to facilitate the testing of Engineering and GMP runs. Lead the QC team to carry out investigations and testing if required for troubleshooting. Identify opportunities to improve technical and operational systems, practices, and technologies. Sample control and Project Management experience. Experience writing Change controls, CAPAs, deviations, Lab investigations and assessments.

Requirements

Required Qualifications: The ideal candidate will possess: Minimum of Bachelors Degree required with 7+ years of Quality Control experience in the Biotech and/or Pharmaceutical industry, or Masters Degree with 5+ years in Biology or other science related filed. GMP experience a Must. The ideal candidate will be well versed in Molecular Biology techniques, qPCR, cell-based assays, Flow, ddPCR, Cell and Tissue Culture operations and principles and has a good understanding of Contract testing. Working knowledge of quality systems and regulatory requirements and work with cross functional teams. Strong knowledge of GMP, SOPs and quality control processes. Strong acumen for analyzing and interpreting data, and statistics. Extensive experience performing laboratory investigations. Must demonstrate a high level of commitment to delivering timelines and milestones to achieve business objective. Ability to communicate and work independently with scientific/technical personnel. Comfortable in a dynamic environment with minimal direction and able to adjust workload based upon changing priorities. Ability to apply GMP regulations and international guidelines to all aspects of the position. Strong organizational skills; ability to prioritize and manage through complex processes/projects. Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems, experience root cause analysis. Ability to utilize various standard computer programs for analytics, statistics, data entry and word processing.

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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