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If your area of expertise is Conducting activities related to the development, qualification and/or validation of new analytical methods or related to modifications of existing methods for pharmacologically active biological particles and for medicinal products using them for registration, preclinical studies and implementation in the technical scale runs and you would like to bring your skillset and experience to a company working in a novel field of biopharmaceuticals, which aims to improve the quality of lives of many patients, this role will allow you to utilize your knowledge. You will be responsible for preparation documentation of research results for the purposes of registering medicinal products under development. Taking care offor the application of EHS and ALCOA principles in the Laboratory of Technical Research and Development - Polpharma Biologics Warsaw.
- Conducting research related to the development of new analytical methods and modification of others existing for control of active substances (pharmacologically active biological particles) and biotechnological medicinal products.
- Conducting analytical method qualification and method transfer to Quality Control section or other external company.
- Performing cell culture maintenance of adherent and suspension cell lines, as well as participating in the development of new cell based assays.
- Performing tests of analytical control of the substances and the drug form during its development and during technical batch runs.
- Analyzing and interpreting the results of research carried out during development and during technical batch runs.
- Keeping records of the research carried out, transfer and/or qualification/validation of methods in accordance with existing standard operating procedures.
- Preparing analytical documentation as per requirement, compilation of results, justification of results and methods, impurities characteristics and others.
- Evaluation of the documentation provided by external companies and other sites concerning analytical methods and conducted tests.
- Developing standard operating procedures and instructions and conducting the training on them.
- Perform maintenance, calibration and qualification of Bioanalytical equipment in accordance with the instructions and procedures.
- Higher education in the field of: biotechnology, biology, biochemistry or related.
- 3 years of experience in laboratory work (analytical or quality control laboratory) in biotechnological or pharmaceutical company.
- Knowledge of analytical techniques such as: Cell culture, ELISA, Immunoassays, alpha LISA, SPR, microplate reader, PLA software, UV/VIS.
- Knowledge of topics related to GxP.
- Experience in writing procedures, protocols and reports.
- Ability to think creatively and to collaborate with other team members to solve technical problems.
- Good managing skills of tasks, time and priorities.
- Knowledge of MS Office.
- Very good command of spoken and written English.
