Technical Expert Bioassay Team
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Technical Expert Bioassay Team.
For the Bioassay team, we are looking for an Analyst/Technical Expert that will actively handle quality and compliance related issues, including low, medium and high-level deviations, CAPA, assessments. To maintain cGMP compliance and LEAN status of the team. You will act as Subject Matter Expert (SME) during cGMP inspections and you will be the New Product Introductions (NPI) contact person during the new product implementation process.
Your responsibilities are:
- Act as a lead investigator for local/global Non-Conformances. Conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions;
- Monitor timely closure of medium/high-level investigations and associated CPA’s;
- Support and advise other lead investigators from external and internal QC departments;
- Co-ordinate activities related to NPI introductions;
- Ensure that assays can technically be executed by the departments concerned in a manner that is efficient, adheres to cGMP and is safe. GAP analysis performed during the new product implementation;
- Craft URS’s in collaboration with ELM RUN team and provide lab input for the new equipment or technologies in the BUILD team;
- Data gathering for assay performance, including raw data. Analyse the assay performance data to relate raw data to assay performance, propose and discuss improvement(s) for the assay(s) with different teams (other sites, DPDS);
- Participate in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines;
- Lead and drive continuous improvement processes.
Who we're looking for
The ideal candidate has a B.Sc. or M.Sc. in a relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry. You have at least 2-4 years of relevant working experience with biological assays and GMP. You have good technical writing skills in English, good knowledge of statistical data analyses and didactical skills, in order to effectively transfer information in a training environment.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Bioassay test team is responsible for testing various samples ranging from early clinical, up to commercial process control, release and stability using different methods and techniques e.g. ELISA, qPCR, Cell Culture.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >3700|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 1 year.
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.