Drug Product Specialist

We are looking for a Drug Product Specialist to join our new department in Gdańsk. In this position you will work on the production processes, to make sure they are in line with the quality requirements and company procedures. You will participate in range of activities in accordance with GMP principles and requirements.

As DP in Gdańsk is a start-up facility, you will be expected to work on the wild range of activities including product transfer, preparing new SOP’s, investigations, training, etc. working in both: office and cleanroom environment.

• Working on documentation and taking part in review and approval process
• Supporting equipment and process qualification activities
• Regular presentation of data, challenges, issues and plans to the Drug Product Manager
• Regular meetings with Operators to plan activities and support problem solving
• Developing and in the future optimizing processes required in Drug Product
• Prioritizing own workflow and assist in prioritizing the workflow of less-experienced colleagues
• Responsible for the equipment preparation, formulation, filling and visual inspection of biologic drug products when required
• Complete assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority
• Maintain cross-functional communication with other departments
• Perform troubleshooting of production support equipment and operations
• Review, edit, complete, and revise completed batch records, in accordance with cGMP standards and compliant with written procedure

• GMP and hands-on experience in Pharmaceutical environment
• Minimum 2 years of experience in Pharmaceutical manufacturing (especially in DP facility)
• Experience in high grades of cleanroom (preferably A/B)
• Knowledge of process monitoring
• Understanding of Microbiology and Sterility issues
• Understanding of root cause analyses and CAPA
• Good understanding of operational excellence
• Positive attitude and good teamwork attributes and you are focused on problem solving and practical approach
• Very good written and verbal communication skills in Polish and English
• Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Strong workload planning skills and attention to detail