DSP Process Matter Expert

For our Technical Operations Department we are looking for a DSP 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 manufacturing of biotechnology products in accordance with GMP principles and FDA requirements.

• Elaboration, verification design and qualification documentation. Participation during equipment and systems qualification.
• Elaboration of SOPs and manuals (including manuals to equipment).   
• Documentation preparation according GMP rules and internal company requirements.
• Participation in technology transfer and process validation in cooperation with MSAT and external Clients.
• Running and monitoring the manufacturing process of biotechnology production according to GMP requirements, technological documentation and other internal requirements.
• Coordination of production team in aim of effective resources utilization, conducting the trainings.
• Close cooperation with the MSAT, Production Operational Department and Quality Department.
• Supervision over schedules related to the preparation of GMP documentation in the Production Department - e.g. procedures, qualification documents, etc.
• Supervision and issuance of system documentation in the Production Department.
• Monitoring the progress of preparation for inspections and audits (external and internal) 

• Higher education in Biotechnology.
• At least 5 years’ experience in biotechnological or pharmaceutical industry.
• Good knowledge of cGMP and FDA requirements.
• Experience in work with recombinant proteins in production scale.
• Experience within protein purification processes. Knowledge of filtration and chromatography techniques.
• Understanding of protein chemistry and interactions related with that.
• Experience in keeping and reviewing process and project documentation according to GMP requirements.
• Excellent knowledge of Single Use Technology used in biopharmaceutical production will be additional advantage.
• Fluent English skills.
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required.