Process Support Manager

For our Technical Operations Department we are looking for a Process Support Manager. On this position you will ensuring stable operations of the Process Support Team and performance of production and validation tasks. 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.

• Coordinating and managing a Team of Specialists and Operators
• Participation and monitoring of technology transfer processes and commercial production in accordance with the principles of cGMP and internal regulations
• Planning and enforcement of production activities in accordance with the Good Manufacturing Practice
• Compliance of all activities undertaken by the Team with the requirements of cGMP, FDA, EMA, ICH.
• Problem solving, explanation of deviations, implementation of changes in accordance with GMP and internal regulations.
• Supporting qualifying activities, supervision of qualification documentation in accordance with GMP and internal regulations
• Supervision of the GMP production area as well as process and system documentation, ensuring an appropriate status enabling continuous work in accordance with the requirements of cGMP.               
• Preparation and review of process documentation in accordance with GMP rules
• Creating system documentation necessary for the smooth operation of the Active Substances Production Department in accordance with GMP standards
• Close cooperating with the Quality Department
• Monitoring the progress of preparation for inspections / external and internal audits      

• Higher education in Biotechnology, Pharmacy or similar
• At least five years’ experience in biotechnological industry and supervision of manufacturing process in accordance to GMP
• Knowledge of USP and DSP Process will be additional advantage
• Experience in work with recombinant proteins                              
• Good knowledge of cGMP and FDA requirements
• Experience in keeping and review process documentation and project documentation according to GMP requirements
• Excellent knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage
• Experience in managing a subordinate team, good organization of own work and subordinates
• Fluent English
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks
• Good knowledge of autoclaving, CIP/SIP, media and buffer preparation processes in industrial scale