As an Upstream Process Development Specialist you will be responsible for conducting activities related to the development, optimization and transfer to production of bioreactor mammalian cell culture processes to obtain a biotechnological product for registration, preclinical research and implementation on a pilot and full-scale scale. Furthermore, you will be also preparing documentation of research results for the purposes of registering medicinal products under development.

Your responsibilities include, but are not limited to:

• Planning and execution of laboratory scale studies to develop, optimize and characterize fed batch and perfusion processes, including small scale model (SDM) establishment and qualification, Process Characterization (PC), small scale studies to assist with process validation;
• Supporting activities related to the creation of USP development laboratory with the use of good laboratory practices as well as organizational and safety standards;
• Writing User Specification Requirements (URS) and participation in the equipment purchase process;
• Performing maintenance, calibration and qualification of equipment in accordance with applicable instructions and procedures;
• Developing procedures and instructions and conducting training on them;
• Providing training and support to younger team members in carrying out their assigned tasks;
• Documenting research results, analyzing the results, drawing conclusions, planning the next stages of research and preparing reports for experimental research;
• Reporting results and conclusions during group, project and other meetings;
• Supporting and supervising the work of team members in the preparation of documents such as SOP, protocols and reports, process description, risk assessment and other laboratory tasks;
• Providing technical and scientific support for laboratory and production operations;
• Independent search and identification of improvements and optimization of the process in terms of technical and economic;
• Support for cGMP production in process scale-up, technology transfer, investigations, and deviations and change control assessment;
• Controlling the consumption and generating purchasing requests for the direct and auxiliary materials, as well as substances and reagents used during the tests;
• Carrying out activities aimed at ensuring the functioning of the laboratory in accordance with the principles of health and safety, hygiene, environmental protection and 6S.

If you have:

• Higher education in the field of biotechnology, biology, biochemistry or related;
• 3 or more years of upstream process development experience in the biotechnology industry, including process development, optimization and process characterization;
• Experience in the processes and techniques of bioprocess in the cultivation of mammalian cells (especially the CHO line);
• Very good scientific knowledge of mammalian cell cultures;
• Experience in writing procedures, complex protocols and technical reports;
• Knowledge of issues related to cGMP and GLP;
• The ability to think creatively and the ability to collaborate with others to solve technical problems;
• Excellent organizational skills;
• Very good command of spoken and written English.

What we offer:

• Competitive salary; 

• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more..