Decoding 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 by ensuring compliance with FDA, cGMP, and international regulatory requirements across manufacturing, testing, product disposition, and quality event management. This role is part of a small QA team with opportunities for cross training into other areas of Quality. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.
Characterizing Your Impact:As the Senior QA Specialist, you will:
- 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 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 acvitivies
RequirementsThe Ideal Transcript:To thrive in this role, you'll need:
- Proven ability to work independently, collaborate with peers, and work effectively in a team environment, all while being highly organized.
- Experience supporting early phas 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 and collaboration.
- Strong problem solving and critical thinking ability and accustomed to risk-based decision making.
- B.S. in a scientific discipline with 4+ years experience within Quality roles in the biopharmaceutical industry.
Fundamentals That Set You Apart- Experience with QC and/or analytical development.
- Experience managing quality systems, vendors, and supporting audit management.
BenefitsEditas 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 Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range: $110,000 - $120,000Pay TransparencyEditas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
