Autolus is looking for a motivated and detail-oriented Operator I to join our GMP manufacturing team in Stevenage. This shift-based role requires weekend working within the operational hours of 6 AM – 10 PM. As part of the Production team, you will contribute to the manufacture and delivery of Autologous cell therapies for patients. This is an excellent opportunity to develop your skills in a cleanroom environment while working within a dynamic and evolving team.
Key Responsibilities
* Execute GMP manufacturing processes under strict regulatory guidelines to produce high-quality cell-based products.
* Follow Standard Operating Procedures (SOPs) and Standard Work Instructions (SWIs) in compliance with Good Manufacturing Practices (GMP).
* Perform cleanroom activities, including cell culture sampling, counting, washing, activation, feeding, and harvesting.
* Support aseptic processing activities such as Magnetic Enrichment & Depletion (MACS), drug product visual inspection, and process adjustments.
* Assist with raw material transfers, environmental monitoring, labelling, reconciliation, and documentation management.
* Maintain a strong focus on safety, quality, and compliance, raising any issues proactively.
* Participate in continuous improvement (CI), root cause analysis (RCA), and corrective & preventive action (CAPA) initiatives.
* Support training and development of junior staff, contributing to a collaborative team environment.
Skills & Experience
* GMP manufacturing or cleanroom experience (essential) or relevant transferable skills.
* Prior experience in shift-based work (essential).
* Ability to work effectively in high-performance environments.
* Strong understanding of GxP production (essential) and knowledge of ATMP manufacturing (preferred).
* Basic awareness of environmental, health & safety requirements.
* Excellent time management, decision-making, and risk assessment skills.
Working Pattern
* This is a shift-based role requiring weekend working.
* Shifts will fall within 6 AM – 10 PM.
* The role is based at our Stevenage manufacturing site, with occasional travel to other locations.
This role offers a fantastic opportunity to grow within a cutting-edge biotech company. If you’re looking to develop your career in GMP manufacturing and be part of an innovative team shaping the future of cell therapy, we’d love to hear from you!
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