MSAT USP Process Matter Expert

For our Manufacturing Science and Technology Department we are looking for an USP Process Matter Expert. On this position you will participate in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in optimization of  biopharmaceutical products manufacturing technologies as well as in troubleshooting, in accordance with GMP principles and FDA and EMA requirements.

• Participation in technology transfer and manufacturing process validation in cooperation with Production, Quality Control and Quality Assurance Departments and external Clients.
• Management and documentation of research activities in the area of upstream, that are used for the therapeutic protein molecules, including monoclonal antibodies, manufacturing 
• Planning and conducting of experiments in the above mentioned area, with particular emphasis on the proper selection of test methods and systemsas well as data analysis
• Close cooperation with similar positions in the field of active substance purification and drug product formulation as well as with the analytical team
• Participation in the creation and approval of standard operating procedures
• Creating guidelines and recommendations for the Production Department   

• Higher education in Industrial Biotechnology, Bioprocess Engineering, Biochemical Engineering or related
• At least 5 years of experience in biotechnological or pharmaceutical industry, in R&D or manufacturing department with developing and scaling-up of drug substances manufacturing technologies with the use of GMM cultures or research unit
• Excellent knowledge of cell cultures techniques, cell metabolism and factors affecting the growth as well as the yield and quality of recombinant protein being produced
• Experience with mammalian cell culture in suspensions (laboratory scale). Additional advantage will be performing cultivation in production scale and scale-up processes
• Knowledge within cell harvesting operations, filtration, centrifugation
• Experience in work with recombinant proteins
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks
• Fluent English