Mammalian Cells Bioprocess Specialist - USP

Miejsce pracy: Gdańsk
Region: pomorskie

Opis stanowiska

Role profile:

  • 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

Wymagania

Requirements:

  • 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

Oferujemy

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

The personal data provided by you will be processed by companies in Polpharma Group i.e. Polpharma Biuro Handlowe Sp. z o.o., having its registered office in Warsaw, ul. Bobrowiecka 6, Zakłady Farmaceutyczne Polpharma S.A. having its registered office in Starogard Gdański, ul. Pelpińska 19, 83-200 Starogard Gdański, Warszawskie Zakłady Farmaceutyczne Polfa S.A. having its registered office in Warsaw, ul. Karolkowa 22/24, 01-207 Warsaw, Medana Pharma S.A. having its registered office in Sieradz, ul. Władysława Łokietka 10, 98-200 Sieradz, in accordance with the Personal Data Protection Act of August 29, 1997 (Journal of Laws of 2002, No. 101, item 926, as amended) for the purpose of the proper performance of current and future recruitment processes carried out by each of the above identified companies. Every person has the right to access their data and correct them. Data submission is voluntary however it is necessary for the proper conduct of the recruitment process.