Interesting position for an experienced analyst with a background in Farma / Analytical Chemisty / Bioassays / Biochemistry at our client Janssen Biologics an important player in the biopharmaceutical industry.
As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Bioassay test team is responsible for execution of the Bioassay test methods using various techniques, ranging from early clinical up to commercial process control, release and stability. For this team, we are looking for an Analyst that will active handle the 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. Act as Subject Matter Expert (SME) during cGMP inspections and is New Product Introductions (NPI) contact person during the new product implementation process.
The jobholder is responsible for deviation management within the Bioassay team.
Data gathering for assay performance, including raw data. Analyze the assay performance data to relate raw data to assay performance, propose and discuss improvement(s) for the assay(s) with different stakeholders (other sites, DPDS)
Analyze and update capacity planning including calculated hours required for performance of the different assays.
Acting 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.
Supporting and advising other lead investigators from external and internal QC departments.
The job holder is 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.
The jobholder is responsible for ensuring that 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.
The jobholder server as Bioassay expert and will be requested to represent the team during internal/external meetings. The jobholder will act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses.
The job holder is responsible for creating URS’s in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established timelines.
Leads and drives continuous improvement processes.
University/Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry
At least 2-4 years of relevant working experience in a (bio) pharmacy.
Experience with release and stability using different methods and techniques e.g. ELISA, qPCR, Cell Culture.
Good technical writing skill in English
Good knowledge of statistical data analyses
Didactical skills in order to effectively transfer information in a training environment.
Contract: 1 year through Oxford Global Resources, Longer-term could be possible depending on business factors, but no promises can be made at this stage;
Salary: €3500,- till €4500,- gross monthly based on level of experience;
Hours full-time preferred 32h discussable;
Holidays: 25 (+12);
Vacancy number; 15479