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QC Bioassay Manager


  Duchnice, Dolnoslaskie   80+ p/h

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  Quality    Contract

This is the opportunity to join a world leading biotech organisation for a 6 month contract with possibility for extension. You will be managing a bioassay team leading on the project delivering on preparation and performance of biological tests.

Responsibilities

  • Run analysis on manufactured batches within the laboratory.
  • Performing all duties in line with current GMP requirements ad pharma regulation.
  • Conducting method transfer, revalidation and method validation.
  • Preparation, review and approval of protocols, reports, methods, and QC documentation.
  • Ensure performance of biological analysis and evaluation of records.
  • Managing a team of 10 individuals developing technical skills and lab techniques.

Qualifications

  • Bachelor's degree or equivalent experience biochemistry, microbiology or natural sciences.
  • 5+ years' experience working with bioassays with practical knowledge of GMP and GDP.
  • 3+ years' experience managerial experience or comparable.
  • Practical knowledge of different bioassay techniques (PCR, ELISA, etc.).
  • Good knowledge of FDA/EMA regulations for bioanalytical methods.
  • Must be located in Poland for the duration of the contract.
  • Fluent in English.

If you, or anyone in your network would be interested please apply or send your CV across to my email: .

Joe.Lane

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