Manufacturing Specialist - 2404

Editas Medicine

Editas Medicine

Waltham, MA, USA
Posted on Wednesday, August 30, 2023

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you

Key Responsibilities & Accountabilities:

  • Full ownership of Manufacturing Deviations, CAPAs and Change Controls (including initiation, investigation, root cause analysis with cross functional groups and closure)
  • Generate, revise, review and approve SOPs, batch records and other quality documents to support internal manufacturing projects and ensure all documents are maintained to accurately reflect the most current process
  • Participate in inspection readiness and inspection support activities, performing data mining when required
  • Recommend/implement process changes/improvements or safety/ergonomic improvements
  • Operations readiness, (monitor material consumption, orders, transactions, material expiry and availability and assist with onboarding new inventory electronic system)
  • Create, assign, perform, and maintain training for manufacturing staff while continuously tracking gap reports as required
  • Support cleanroom operations including review and tracking of equipment records for PM/calibration and cleanroom maintenance and cleaning

Knowledge, Skills & Capabilities:

  • Must have experience with Cell Therapies
  • Must have experience working in a GMP environment
  • Must have technical knowledge to work as a liaison between MFG, Process Development, Quality Control and Quality Assurance
  • Must have experience with GMP document creation/revision
  • Must have experience with Excel and Microsoft Office applications
  • Must have ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
  • Must have experience with Quality Management Systems
  • Must have ability to work flexible hours to complete work activities
  • Must have ability to make decisions and work with minimal to moderate supervision
  • Strong organizational skills and attention to detail with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
  • Excellent verbal and written communication skills
  • Preferred experience with gene editing processes

Education & Relevant Work Experience:

  • BS in Biology-related field of study with minimum 5-6 years of experience in a GMP environment

Physical & Travel Requirements:

  • Must be willing and able to travel between Devens and Waltham locations

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.