Strona główna

As a member of our Technical Operations department 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.

• Carry-out and monitoring of biotechnological production processes according to technological documentation, GMP rules and internal quality requirements in scope of downstream processes – purification, filtration and formulation during drug substance manufacturing
• Analysis of achieved process data according to compliance with technological documentation and internal requirements
• Participation in technology transfer and process validation in cooperation with Research and Development Department and MS&T
• Preparation of documentation according to GMP rules and Company internal requirements
• Preparation of Standard Operational Procedures and instructions
• Guarantee of effective production activities preparation and carry out, responsibility for production process continuity, reporting of performed actions statuses
• Supervision of proper raw materials expenditure during technology transfer and production processes.
• Shift work