Analyst Bioassay Team
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for an Analyst Bioassay Team .
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.
For the Bioassay team, we are looking for an Analyst that will actively handle quality and compliance related issues, including medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls. 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:
- 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 stake holders (other sites, DPDS);
- Analyse and update capacity planning including calculated hours required for performance of the different assays.
- Act as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions;
- Support and advise other lead investigators from external and internal QC departments;
- Responsible for the proper lab investigation and CRA’s for the medium/high-level Quality issues;
- Monitor timely closure of medium/high-level investigations and associated CRA’s;
- Ensure assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe. This could be accomplished by means of the GAP analysis performed during the new product implementation;
- Serve as Bioassay expert and will be requested to represent the team during internal/external meetings. You will act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses;
- Create URS’s in collaboration with ELM RUN team and provide lab input for the new equipment or technologies in the BUILD team;
- 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, with at least 2-4 years of relevant working experience in (bio) pharmacy. 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.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 1 year
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555