QC Microbiology Data Reviewer

Legend Biotech • Fulltime • Bridgewater Township, NJ, USA, United States • 3m ago

Company Information

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 QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ.

Role Overview

The QC Microbiology Data Reviewer is an exempt level position with responsibilities for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities

Responsible for reviewing routine EM sampling, including viable/non-viable air and surface sampling, related to Raritan manufacturing processes, either for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
Create, review and approve relevant QC documents, logbooks, 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 including endotoxin, sterility, growth promotion, as well as other microbiological assays.
Utilize electronic systems (LIMS) for execution, documentation, review of testing.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Other duties will be assigned, as necessary.

Requirements

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 preferred.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products 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 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.

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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.