Physicochemical Junior Specialist TR&D

Your responsibilities include, but are not limited to:

• Performing analytics to support Process Development as per requirements, as well as for Stability, Similarity and Comparability studies and any other study developed in TR&D.
• Participate in analytical method qualification and method transfer to Quality Control section or other external company.
• Participate in the development of new analytical methods and modification of others already existing for control of active substances (pharmacologically active biological particles) and biotechnological medicinal products.
• Analyzing and interpreting the results of research carried out during development and during technical batch runs.
• Keeping records of the carried out research, transfer and/or qualification of methods in accordance with existing standard operating procedures and principles.
• Write standard operating procedures and instructions and be trained on them.
• Perform maintenance, calibration and qualification of lab equipment in accordance with the instructions and procedures.
• Review the literature provided by specialists regarding new analytical control methods or technologies for new substances and biotechnology drug forms.
• Control the usage of materials and reagents during lab activities, management of stocks and preparation of purchasing requests.
• Give support on any activity related to the preparation of Analytical Development laboratory with the use of Good Laboratory Practices as well as organizational and safety standards.
• Write User Specification Requirements (URS) and participation in the equipment purchase process.
• Support the work of team members in the preparation of documents such as SOP, protocols and reports, and other laboratory tasks.

If you have:

• Higher education in the field of: biotechnology, biology, biochemistry or related.
• 1-2 years of experience in laboratory work (analytical or quality control laboratory) in biotechnological or pharmaceutical company.
• Basic knowledge of analytical techniques such as HPLC/UPLC.
• Basic knowledge of topics related to GxP and data integrity.
• Good management and writing of documentation.
• The ability to think creatively and the ability to collaborate with others to solve technical problems.
• Good organization at work and time management.
• Knowledge of MS Office.
• Very good command of spoken and written English.