Senior QA Specialist
About the company
At Editas Medicine, we are pioneering the possible. Our mission is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. We aim to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
We're a team of passionate problem solvers, harnessing CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed through collaboration, mutual respect, and innovation.
About the role
The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic to establish human proof of concept. This involves ensuring compliance with FDA, cGMP, and international regulatory requirements across manufacturing, testing, product disposition, and quality event management. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels, demonstrating over 90% reduction in mean LDL cholesterol levels in non-human primates.
This role is part of a small QA team with opportunities for cross-training into other areas of Quality.
Responsibilities
- Maintain Quality oversight of GMP operations including batch record review, analytical results, certificates of analysis, and Quality Events (e.g., deviations and change controls).
- Disposition lots.
- Provide Quality review of assay validation, test method development, and other technical documents.
- Collaborate with, oversee, and support partner CDMOs/CTOs.
- Develop a comprehensive understanding of the manufacturing processes for Editas products and the associated risk management control strategy to identify process risks and critical controls around processing steps.
- Author, review, and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, specifications, and summary reports) supporting GMP manufacturing.
- Establish, implement, maintain, improve, monitor, and report on quality and compliance systems.
- Assist in Quality System and Vendor Management activities.
Requirements
- Proven ability to work independently, collaborate with peers, and work effectively in a team environment while being highly organized.
- Experience supporting early-phase Quality and working with CDMOs/CTOs.
- Experience with batch record review and lot release.
- Working knowledge of GMP requirements for Clinical Trial Material in global markets, including understanding of regulatory guidance on gene therapy products.
- Experience with biologics, protein, RNA, cell/gene therapy, and/or viral products.
- Expertise working within cGMP compliance and providing GMP documentation.
- Strong communication, collaboration, problem-solving, and critical-thinking skills.
- Accustomed to risk-based decision making.
- B.S. in a scientific discipline with 4+ years of experience within Quality roles in the biopharmaceutical industry.
Preferred Qualifications
- Experience with QC and/or analytical development.
- Experience managing quality systems, vendors, and supporting audit management.
Benefits
- Blue Cross Blue Shield PPO Medical Plan.
- 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 Assistance Plan.
- Wellness Programs.
- Flexible Paid Time Off policy.
Pay
Salary Range: $110,000 - $120,000. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, relevant experience, external market conditions, the role's criticality, and internal equity.