Process Development Expert
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Role:
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 biotechnology products with the purpose of registration, preclinical studies, and implementation in the pilot-plant scale.
Your responsibilities
- Lead/oversight of process development planning/troubleshooting and data analysis
- Knowledge transfer - training specialists in key USP & DSP 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
- 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 to other biopharma
- Identification of needs with regards to data analysis, automation 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
- 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.
- Industry-leading theoretical and practical knowledge of the applied to Upstream process development
- Industry-leading 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 English