Quality Control Phys-Chem Senior Specialist
ROLE AND RESPONSIBILITIES:
- Performing quality control testing at all production stages as well as drug substance and drug product release and stability testing;
- Performing bioanalytical and physicochemical tests according appropriate procedures for testing biopharmaceutical products and raw materials;
- Participation in bioanalytical and physicochemical method transfers and validations;
- Establishing new QC laboratories, keeping and improving the labs;
- Reviewing, verification, trending and interpretation of analytical results;
- Planning and performing analytical method validations including preparing all related documentation;
- Initiating quality investigations and participating in CAPA implementation;
- Change control processes initiation and cooperation during implementation;
- Preparation of Standard Operating Procedures, Instructions and Analytical Methods;
- Performing maintenance, calibration and qualification of laboratory equipment according to instructions and procedures;
- Supervising work of technicians and junior specialist in the assigned tasks;
- Participation in trainings and training other analysts.
- Higher education with a specialization in the fields: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related;
- Five years of laboratory experience in regulated environment;
- Knowledge of: bioanalytical methods i.e.: blotting, ELISA, SPR, RT-PCR and liquid chromatography used for testing biological drugs (peptide mapping, size exclusion, ion exchange) and capillary electrophoresis, UV-VIS spectrophotometry;
- Practical and theoretical knowledge about transfer and validation of methods, liquid chromatography concerning work with biologic drugs (such as: peptide mapping, size exclusion, ion exchange), capillary electrophoresis, UV-VIS spectrophotometry;
- Very good command of English, both written and spoken;
- Knowledge of pharmacopeia methods for raw materials testing;
- Knowledge about conduction and managing stability studies will be an advantage.
- 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 in modern laboratories 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.email@example.com.