Physicochemical Properties Analytics Senior Specialist

We are looking for a Physicochemical Properties Analytics Senior Specialist to join our department of Technical Research and Development. You will work on the development and validation of new analytical methods of control or on modification of existing methods for pharmacologically active biological particles and for medicinal products using them for registration, preclinical studies and implementation in the pilot-plant scale.

• Reviewing the specialist literature in order to select the appropriate analytical control methods for new substances and biotechnology drug form
• Conducting (independently) research related to the development of new and modification of existing analytical methods for control of active substances (pharmacologically active biological particles) and biotechnological medicinal products
• Conducting analytical method qualification and method transfer to quality control
• Performing tests of analytical control and evaluating (independently) the quality of the substances and the drug form during its development and in pilot-plant scale
• Performing validation of selected analytical methods
• Analyzing and interpreting the results of research carried out individually or by co-workers
• Keeping records of research and validation of methods in accordance with existing standard operating procedures and the principles
• Preparing analytical documentation required in the registration and implementation of new biotechnological drugs processes such as: specifications and test methods, compilation of results, justification of specifications and methods, impurities characteristics and other
• Developing standard operating procedures and instructions and conducting the training on them
• Developing manuals of physicochemical equipment and other devices, conducting trainings on them
• Performing maintenance, calibration and qualification of physicochemical equipment in accordance with the instructions and procedures
• Controlling the usage and preparation demands for direct and supporting materials as well as substances and reagents used during the research

• Higher education with a specialization in the fields: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related (PhD would be an advantage)
• Minimum 5 years of experience in laboratory work (analytical or quality control laboratory)
• Knowledge of analytical techniques such as: liquid chromatography (ion-exchange chromatography, affinity chromatography, hydrophobic interaction chromatography, and reverse and normal phase chromatography), UV/VIS, IR spectroscopy, mass spectrometry, and electrophoretic techniques
• Knowledge of software for operating analytical equipment; experience in working with Empower software will be an advantage
• Knowledge of issues related to cGMP and GLP
• Good knowledge of spoken and written English
• Knowledge of MS Office
• Good organization of work and time
• Ability to cooperate with others in order to solve problems