Supervisor Bioassay team - One JSC Lab Leiden As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, Bioassay test team is responsible for execution of all analytical test methods using various bioactivity and identity techniques, ranging from early clinical up to commercial process control, release and stability. For our team, we are looking for a Supervisor that will lead the Bioassay team and ensure the day-to-day operations of the team. The key responsibilities of the jobholder:
Responsibilities & Accountabilities
The Supervisor leads 8-12 lab technicians and is accountable for the personnel in the team and their performance & development by performing the 5 conversations. Accountable for effective team performance by setting objectives in line with the ONE JSC Lab Organization business strategy.
The Supervisor leads and defines team execution testing activities that are compliant with the cGMP and safety regulations. Furthermore, the Supervisor assures all test related elements are in place e.g. materials, equipment, trained personnel etc. in order to complete all testing activities in a timely manner.
The Supervisor has the primary accountability for planning, organization, day-to-day supervision and execution of daily tasks within the team and ensures the seamless transfer of activities using SmartQC.
The Supervisor assures that the assays are performed to the required quality and quantity and sets priorities in case of conflicting situations within the ONE JSC Lab Organization. The Supervisor oversees all monitoring and reporting of all critical activities (e.g. process/delay of testing). If necessary, undertake actions independently and assures relevant action plan is in place (e.g. earned hours etc).
The Supervisor deals appropriately with any deviations, OOT/ OOS results corresponding CAPAs and Change controls on a defined team level and notifies involved ONE JSC Lab management. The supervisor will be responsible for closure of all low impact deviations. Additionally, the Supervisor ensures the proper coordination of investigations on a defined team level to achieve resolution in the minimum time and in compliance with GMP principles.
The Supervisor is responsible for following up on relevant KPIs, which includes but are not limited to, 6S/housekeeping, invalid assay rate, training status of the team, lead time of test results.
The Supervisor is responsible for creating team environment for continuous improvements applying the Business Excellence and Faster Forward tools.
* MBO/HBO/WO diploma in relevant field
* Few years relevant work experience, of which at least 1 year in a demonstrable supervisory capacity.
* GMP knowledge required
* Knowledge or affinity with the relevant test methods
* Good interpersonal and organizational skills
* Good communication skills
* A quality, compliance and business minded attitude and flexibility
* Knowledge and affinity with Business Excellence and Faster Forward mindset
For more information, and to apply, please send me your most recent CV + Cover Letter to: j.vanbaalen(@)progressive-nl.com