Are you an experienced Production Operator interested in joining our biotech client that is leading the way in developing innovative CAR-T cell therapies for cancer treatment?
Our client is looking for a highly motivated Operator II to join their GMP manufacturing team. This is a shift-based role that involves weekends and shifts that fall within the operating hours of 6AM-10PM. You will play a key role in ensuring the production of high-quality cell-based products while maintaining compliance with GMP regulations, safety standards and company procedures.
Responsibilities:
Execute production processes and operate associated equipment in line with GMP and GDP requirements.
Maintain cleanroom environments through sterile room maintenance, hydrogen peroxide vapour gassing, and environmental monitoring (EM).
Conduct raw material transfers, particulate cleaning and disinfection, material receipt, and drug product shipment.
Accurately complete documentation and data entry, ensuring compliance with regulatory standards.
Perform cell culture activities including sampling, counting, washing, activation, feeding, harvesting, and magnetic enrichment/depletion (MACS).
Carry out aseptic manipulations in Grade A environments and meet associated BROTH qualification (OAQ) standards.
Support batch review execution and collaborate with cross-functional teams to ensure smooth workflow.
Lead or support operational deviations, process risk assessments, and continuous improvement (CI) initiatives.
Assist in the authoring and revision of SOPs, SWIs, and risk assessments to maintain process efficiency and compliance.
Provide guidance and mentoring to junior team members, supporting their training and development.
Follow all SOPs/SWI applicable & in which the individual has been trained and always act in compliance with GMP & to proactively raise any issues
Required Experience
Minimum 2 years GMP manufacturing cleanroom experience
Exposure to high performance/stress conditioned work
Demonstrate detailed understanding of GxP / sterile / ATMP production
Demonstrate proficiency in environmental, health & safety requirements
Ability to follow detailed instructions and make quality-critical decisions
Preferred Experience:
Experience working in a shift-based environment
Familiarity with problem-solving methodologies like Lean Six Sigma
This role offers an exciting opportunity to be part of an innovative biotech company, contributing to the manufacture of next-generation cell-based therapies. If you're passionate about GMP manufacturing and eager to make a difference, we’d love to hear from you
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