Mammalian Cells Bioprocess Specialist - USP
Place of work: Gdańsk
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
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
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
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.