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
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.