Lead Qc Microbiology Data Reviewer - Raritan, United States - Legend Biotech US

Legend Biotech US
Legend Biotech US
Verified Company
Raritan, United States

3 days ago

Mark Lane

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Mark Lane

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Description

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
Lead QC Microbiology Data Reviewer as part of the
Quality team based in
Raritan, New Jersey.



Role Overview


The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for leading a team of microbiology data reviewers supporting the 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.

The lead QC Microbiology Data Reviewer will also be responsible for the completion of environmental monitoring trend reports.


Key Responsibilities

  • Scheduling of daily activities for direct reports.
  • Completion of routine environmental monitoring trending.
  • Ontime completion of microbiology trend reports.
  • Responsible for reviewing routine EM sampling, including viable/nonviable 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, reevaluate 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.

  • Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and
applicable pharmacopeia while remaining current in on-the-job training 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.

  • 6+ years relevant work experience,
preferably within a biological and/or
pharmaceutical industry is required.

  • Experience with microbiology testing
preferred.

  • Extensive experience trending data
  • Experienced with completion of
microbiological trend reports.

  • Strong Microsoft Excel experience
Legend Biotech maintains a drug-free workplace.
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