Main Responsibilities
* Design, develop, improve, and validate analytical methods for existing and new production processes.
* Independently design experiments and develop comprehensive analytical studies.
* Generate high-quality scientific/technical study protocols and reports.
* Maintain and communicate critical documentation and knowledge.
* Perform data trending and monitoring of analytical methods to ensure reliability and effectiveness.
* Conduct root cause investigations for analytical deviations.
* Present results and findings at team meetings.
* Support small-scale testing activities in the laboratory.
Experience:
* PhD in Life Sciences, Biochemistry, Biotechnology equivalent through experience.
* strong hands-on expertise with ELISA and qPCR methods, particularly for host cell impurity analysis.
* Knowledge of protein characterization techniques (SDS-PAGE, Western/Southern/Northern blots) is advantageous.
* have proven experience in analytical method development, qualification/ validation.
* have excellent analytical problem-solving mindset
* independently draw up a plan for the projects in need of support.
* handle multiple projects at the same time.
* willing to support both laboratory work and desk-based analysis.
* good technical writing skills and able to prepare protocols and reports.
* critically analyze data, draw scientifically sound conclusions, and formulate them correctly.
* perform basic statistical analysis and interpret method performance parameters.
* design and execute DOE experiments for qualification/validation of analytical assays and interpret complex datasets.
* excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans.
Languages:
* Dutch
* English, fluent in writing and speaking