Process Development Expert
Gdańsk
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For our TR&D department, we are currently looking for a person who will be carrying out work on the development, transfer, and optimization of processes for therapeutic biotechnological products.
Your responsibilities
- Lead/oversight of process development planning/troubleshooting and data analysis
- Knowledge transfer in key USP development aspects
- Leading the implementation of new technologies – proposal, planning, and execution
- Supervision of implementation projects – reporting on the progress, managing assigned resources, and troubleshooting
- Supporting process transfer activities
- Scouting new solutions on the market
- Creating strategy and a generic flow/system for process development of biosimilars, also based on lessons learned from previous projects
- Benchmarking development strategies
- Identification of needs with regards to data analysis, automated systems, equipment utilization, and upgrade
- Close cooperation in early process development stage or lead/oversight of technology transfer and scale-up to cGMP areas.
- Content review of key process documents (reports, protocol, etc..) and providing expert input
If you have
- Higher education in Biotechnology, Biology, Pharmacy or related
- At least 5 Years in biotech USP/DSP development / MS&T
- Tech transfer & scale-up experience from R&D to cGMP environment.
- Project management experience – function lead preferred
- Fluency in written and spoken English.
- Theoretical and practical knowledge of the applied to Upstream process development
- Theoretical and practical capability to perform all relevant activities pertaining to successful completion of product design activities in USP and DSP development
- Capacity of writing protocols, instructions, and reports in English