USP Production Team Leader

The USP Production Team Leader is responsible for participation in the production process of biotechnology products in accordance with the GMP principles and FDA requirements to obtain a product of the specified quality in the specification for registration. Participation in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of internal and external biotechnology products. Managing of Operator's work during the shift.

• Participation in the design process, implementation of the production area,
• Responsibility for the purchase, qualification of production equipment,
• Experienced in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products,
• Manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification,
• Elaboration of SOPs and manuals ( including manuals to equipment),
• Running and monitoring the manufacturing process of biotechnology product according to GMP requirements, technological documentation and other internal requirements,
• Writing Completion and Review of cGMP paperwork, (SOPs, Batch Records),
• Attending of process validation in cooparation with Reaserch and Developmet Department/ Client,
• Organizing your and team's work in order to make the most effective use of working time and performance of tasks,
• Leads the shift group and responsible of team members.

• Higher education (at least Msc) in Biotechnology, Pharmacy or similar,
• At least 5 year experience in biotechnological or pharmaceutical industry
• 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 with mammalian cell culture. Additional advantage will be performing cultivation in production scale according to GMP rules.
• Very good speaking and writing English skills,
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required,
• Knowledge of MS Office and AutoCAD.