• Anywhere

Days ~Onsite. Initial 12-month contract role.

Position Summary:

Reporting to the Team Lead, Bioassay BTDS AD Cork, The Bioassay group support testing of DPC, VIN and FB product for Bioactivity testing, process impurities, identity testing.

Main duties and responsibilities:

  • Routine release and stability testing of binding assays (e.g., ELISA and -FRET), cell-based bioassays (e.g., ADCC assays), process impurities and identity assays for pre-clinical and clinical product development.
  • Execution of process impurity assays (e.g., residual host cell protein (HCP), residual DNA (PCR techniques) and residual Protein A).
  • Completion of documentation in adherence to GMP.
  • Testing to support assay validation/qualification and other studies.
  • Laboratory support activities (e.g., reagent qualification), routine passaging of cell lines and general housekeeping.
  • Support other projects as assigned, e.g., Continuous improvement, automation, and operational excellence.
  • Support troubleshooting and investigations.
  • Perform Data Trending to support investigations, demonstrate method capability and product profile.
  • Performs advanced tests and analyses to assure that products align with established specifications.
  • Carries out complex calculations and documents test results.
  • This is a volume driven position that that directly touches product.
  • Compiles and analyzes data on reoccurring product defects to determine root cause.
  • Analyzes raw material inspection logs for consistent failures.
  • Notifies purchasing and quality departments about suppliers that have provided inferior products.
  • Studies work processes, measurements and performance metrics to identify improvement areas.

Key Skills / Competencies and required Education

  • Minimum of 3 years of practical analytical laboratory experience in a GLP/GMP environment is essential.
  • Minimum of 3 years experience in Cell culture and ELISA/ DNA/ HCP/ Protein A/ Cell based assays.
  • Experience of Bioassay/Cell Culture experience is advantageous.
  • Familiar with applicable cGMP and other business compliance regulations.
  • A minimum of a level 8 degree in Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
  • Knowledge of computer programs such as MS Word, Excel and Minitab.

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