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Supervisor, QC Micro
4 months ago
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Supervisor, QC Micro as part of the Quality Control team based in Raritan, NJ.
Role Overview
The QC Microbiology Supervisor, CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Key Responsibilities
- Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
- Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
- Create, review and approve relevant QC documents, SOP's and WI's.
- Ensure microbiological control strategy is consistent with cGMP requirements.
- Participate in training and delivery of Operations aseptic technique and microbiology awareness training program.
- Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
- A Minimum of 2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
- Experience in a Quality Control setting is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred.
- Detailed knowledge of the shop floor manufacturing process is preferred.
- Comprehensive knowledge of trending using statistical analysis is preferred.
- Ability to pay attention to details and follow the procedures 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.
- Comfortable with speaking and interacting with inspectors.
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- This position may require up to 10% domestic or international travel as business demands.
#LI-NP
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
