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Polpharma Biologics

Quality Control Phys-Chem Senior Specialist

Polpharma Biologics

Gdansk, Poland

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.

REQUIRED QUALIFICATIONS:

  • 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.

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 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.

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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