Manufacturing Associate - 2430
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 & Accountabilities:
- Assist in leading/training a clinical MFG team in a clean room environment while fully gowned following GMP guidelines and using aseptic technique.
- 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
- Lead troubleshooting of process and equipment problems with manufacturing, process development and quality teams
- Operate instrumentation required for cell manufacturing and gene editing.
- Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under GxP guidelines as directed.
- Work in a Biological Safety Cabinet for open processing operations.
- Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation.
- Maintain orderly lab space.
- Maintain sufficient inventory of supplies and reagents for performance of duties. Clean and maintain laboratory equipment in good working order.
- Prepare solutions and culture media as appropriate.
- Work in compliance with all appropriate laboratory regulatory and safety requirements.