QC Microbiology Specialist I

2 weeks ago

Raritan, New Jersey, United States Legend Biotech USA Full time
Job Description

Legend Biotech is seeking aQC Microbiology Specialist, Lentivirus CAR-T Manufacturingas part of theQualityteam based in Raritan, NJ.The current openings are on the second and third shift.

Role Overview

The QC Microbiology Specialist, Lentivirus Vector (LVV) CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the LVV facility to support clinical trials and commercial operations in a controlled GMP environment.

Major Responsibilities

  • Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of LVV used for autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment
  • Responsible for performing compressed gas sampling in the manufacturing LVV facility
  • Work with Process Development team, Quality and Operations organization to successfully transfer LVV manufacturing process to cGMP facility
  • Create, review and approve relevant QC documents, SOP's and WI's
  • 5Ensure microbiological control strategy is consistent with cGMP requirements
  • Participate in training and delivery of Operations aseptic technique and microbiology awareness training program
  • Support Aseptic Process Simulations and visual inspection of components
  • 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

Key Relationships

Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development

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 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
  • Knowledge of Aseptic Process Simulations 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

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