Mammalian Cells Bioprocess Specialist - USP
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.
- 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.
- 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.
Please send your CVs directly to: Malgorzata.firstname.lastname@example.org.