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Mammalian Cells Bioprocess Spe...

Mammalian Cells Bioprocess Specialist - USP

Currently we’re looking for


Mammalian Cells Bioprocess Specialist - USP
Location: Gdańsk

We are waiting just for you!

What will you do?

  • Carry-out and monitoring of biotechnological production processes according to technological documentation, GMP rules and internal quality requirements
  • Analysis of achieved process data according to compliance with technological documentation and internal requirements
  • Participation in technology transfer and process validation in cooperation with Research and Development Department
  • Preparation of documentation according to GMP rules and Company internal requirements
  • Preparation of qualification documentation for production equipment, participation and carry out of equipment qualification
  • Preparation of Standard Operational Procedures and instructions and trainings for its introduction
  • Guarantee of effective production activities preparation and carry out, responsibility for production process continuity, reporting of performed actions statuses
  • Supervision of proper raw materials expenditure during technology transfer and production processes.
  • Shift work

What do we expect?

  • Higher education (at least Msc) in Biotechnology, Pharmacy or similar
  • At least two year experience in biotechnological or pharmaceutical industry
  • Good knowledge of cGMP and FDA requirements
  • Experience in keeping records in production documentation according to GMP requirements
  • Excellent knowledge of aseptic techniques especially used in in vitro cell cultures is required
  • Knowledge and experience in mammalian cell cultures (especially coherent cell lines) is required
  • Experience in work with bioreactors will be an additional advantage
  • Experience in work with recombinant proteins will be an additional advantage
  • Experience in single use materials usage for biopharmaceutical production will be an additional advantage
  • Very good speaking and writing English skills
  • Knowledge of MS Office
  • Good work organization and individual problem solving skills are required
  • Good communication, team cooperation skills and being open for new tasks is required