This team’s primary responsibility is to develop and validate analytical methods for release, stability testing and in-process control of our biological drug substances and products, according to the required GMP and regulatory standards from early clinical phases to life-cycle management of the product. The team is also involved in method transfers and preparation of regulatory submissions with internal or external business partners.
The primary goal of the mission is to develop and validate the methods used for the release and stability testing of UCB Biologicals as appropriate, according to the agreed quality standards and timelines. The incumbent will work in a team environment, collaborating with various scientists and technicians in cross-functional project teams.
The main techniques used are HPLC/UPLC, ICP-MS, qPCR, gel/capillary electrophoresis, immunoassays.
What you’ll do
- Participate in development of analytical methods
- Participate in (co-)validation or verification of analytical methods.
- Analyse results
- Verify data
- Perform daily laboratory activities related to release and stability testing
- Follow up deviations, incidents and validate the results.
- Participate to method transfers from different laboratories
- Participate in writing the documentation related to the lab activities
- All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product.
- Bachelor degree, or master’s degree, in biochemistry or in analytical chemistry
- Previous experience preferably in the biotech industry
- Good knowledge of method validations
- Strong and proven laboratory skills
- A good practical experience and expertise in at least one of the analytical techniques used in the laboratory: HPLC/UPLC, ICP-MS, qPCR, gel/capillary electrophoresis, immunoassays.
- A good knowledge of GMP standards
- Good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
- Good knowledge of English (ability to read scientific documents)
- Well organized, flexible, meticulous and rigorous, proactive, with a strong team spirit
- Able to work in a multicultural environment.