Beschreibung
We are recruiting for Senior Technical Writer/Senior Expert Biologics Analytical Development.
As part of the analytical project team you will be responsible for the coordination and planning of analytical activities, which will involve close interaction with senior experts from other line functions.
This is a 12 month contract position.
Responsibilities:
- You will author analytical reports
- Perform risk assessment
- Support the preparation of analytical sections of CMC dossiers.
Minimum Requirements:
- PhD in Biochemistry, Chemistry or a related field
- 5 years of relevant experience in the biotechnology industry.
- Excellent understanding of the technical development of protein biopharmaceuticals and physicochemical protein characterization techniques (eg chromatography, electrophoresis, mass spectrometry)
- Excellent understanding of the drug development process, including critical and objective assessment of scientific information and drawing of relevant conclusions is a must.
- Proven track record in scientific writing and/or preparation of regulatory submission documents
- Excellent interpersonal and organizational skills
- Excellent written and oral communication skills in English
Michael Bailey International is acting as an Employment Business in relation to this vacancy.