This team's primary responsibility is to perform release and stability testing according to the required GMP and regulatory standards from early clinical phases to phase III. The team is also involved in method transfers, co-validations, specification settings and preparation of regulatory submissions with internal or external business partners.
Scope of the mission:
The primary goal of the mission is to contribute to the release and stability testing of Biological product, 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 pharmacopeia tests, HPLC/UPLC, gel/capillary electrophoresis, immunoassays.
The main activities of this position will be:
- Perform daily laboratory activities related to release and stability testing
- Analyse results
- Verify data
- Work with other analysts in organizing the release and stability analyses of the laboratory
- Follow up deviations, incidents and validate the results within a LIMS system.
- Participate to method transfers from different laboratories
- Participate in co-validation or verification of analytical methods.
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.