Downstream Process Development Specialist
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:
In this position you will be tasked with activities needed for the purpose of development, characterization and optimization of downstream processes as well as transfer of the proper technologies.
Your responsibilities:
- Planning and execution of laboratory scale studies for the purpose of development and optimization of protein purification steps, including chromatography, filtration and membrane separations
- Documented observations, analyzes of data, reporting of results and conclusions for each experimental study
- Troubleshooting activities and deviations’ assessment
- Assessing improvements in DSP setup
- Optimization of the process with regards to technical as well as its economic aspects
- Evaluation of external suppliers of resins, filter membranes, disposable materials etc.
- Supporting GMP manufacturing through process investigations and during process transfer
- Design and execution of experiments based on DoE approach
- Collaboration with USP, Analytical and Pilot Plant departments in order to achieve optimal results
- Supporting and coordinating work of junior team members in their assigned tasks
If you have:
- University degree in Biotechnology or related disciplines
- 2+ years of experience in purification process development (preferably antibodies) in the industry is highly desirable, however the candidates with strong experience and demonstrated track record in the development and optimization of protein purifications in university/academia will also be considered
- Knowledge of fundamentals of protein expression systems and upstream process development
- Experience in working with quality and process documentation
- Experience with TFF and normal-flow filtration
- Strong understanding of protein chromatography
- Proven ability to work independently in the hands-on laboratory setting
- Experience in handling lab-scale chromatography systems (such as ÄKTA systems) is required
- Analytical skills and knowledge of spectrophotometric methods is desired
- Experience with writing technical development or scientific reports/publications
- Tech transfer & scale-up experience from R&D to cGMP environment is a plus
- Basic knowledge of GMP standards is a plus
- Fluent English
- Capacity of writing protocols, instructions, and reports English