Legend Biotech US
QC, Analyst I
Raritan, New Jersey, United States
Sponsorship not specifiedDetected 7 days ago
Code ReviewProject ManagementClinical TrialsGMPFDA RegulatoryCommunicationCollaborationOrganizational Skills
About the role
- The QC Analyst (IPL) is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
- Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Responsibilities
- Perform peer review/approval of laboratory data.
- Create, review and approve relevant QC documents, SOP's and WI's.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Requirements
- Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
- Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
- Knowledge of Good Tissue Practices is required.
- Excellent written and oral communication skill are required.
- Candidates must be able to accommodate shift schedule.
- Shifts include routine weekend and evening work as required by the manufacturing process.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Nice to have
- Experience in a Quality Control setting is preferred.
- Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
- Knowledge of CAR-T QC test methods and related equipment is preferred.
Skills
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases.
Compensation
- The base pay range below is what
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This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.