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Polpharma Biologics

Mammalian Cells Bioprocess Specialist - USP

Polpharma Biologics

Gdansk, Poland

ROLE AND RESPONSIBILITIES:

  • 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 carrying out of equipment qualification;
  • Preparation of Standard Operational Procedures and instructions and trainings for its implementation;
  • Ensuring 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.

REQUIRED QUALIFICATIONS:

  • Higher education (at least Msc) in biotechnology, pharmacy or similar;
  • Minimum two year experience in biotechnological or pharmaceutical industry;
  • Good knowledge of cGMP and FDA requirements;
  • Experience in keeping records of production documentation according to GMP requirements;
  • Excellent knowledge of aseptic techniques especially used in in vitro cell cultures;
  • Knowledge and experience in mammalian cell cultures (especially coherent cell lines);
  • Experience in work with bioreactors and recombinant proteins will be an additional advantage;
  • Experience in single use materials usage for biopharmaceutical production;
  • Very good command of English, both written and spoken;
  • Knowledge of MS Office;
  • Good work organization and individual problem solving skills;
  • Good communication, team cooperation skills and being open for new tasks;
  • Readiness to do shift work.

WE OFFER:

  • Employment contract with opportunity to help shape the success of a leading private pharmaceutical company;
  • Working in a cutting edge biotech laboratory and great opportunity for professional development and participation in training programs;
  • Competitive salary, performance-related bonus and attractive fringe benefits;
  • Interesting challenges, possibilities of comprehensive professional development;
  • Working with world class equipment;
  • Multicultural and dynamic team of enthusiasts.

More information about Polpharma Biologics you will find on our website www.polpharmabiologics.com.

We also encourage you to get familiar with our corporate movies: Polpharma Biologics movie 1 and Polpharma Biologics movie 2.

Please send your CVs directly to: Malgorzata.delke@polpharma.com.

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