As a part of the laboratory situated at the Janssen Biologics Manufacturing site in Leiden, The 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. As supervisor you have broad responsibilities in leading the team.
- Leading 8-12 lab technicians and accountable for the personnel in the team and their performance & development;
- Accountable for effective team performance by setting objectives in line with the business strategy;
- Leading and defining team execution testing activities that are compliant with the cGMP and safety regulations.
- Assuring all test related elements are in place e.g. materials, equipment, trained personnel, etc.
- Primary accountability for planning, organization, day-to-day supervision and execution of daily tasks within the team and ensuring the seamless transfer of activities;
- Assuring that the assays are performed to the required quality and quantity and sets priorities in case of conflicting situations.
- Overseeing all monitoring and reporting of 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).
- Dealing with any deviations, OOT/ OOS results corresponding CAPAs and Change control.
- 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.
- MLO/HLO/WO diploma in relevant field (Biotech, life science);
- >4 years 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;
- English Required, Dutch is considered a plus;
- 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 €4300,- gross monthly based on level of experience;
- Hours full-time preferred 32h discussable;
- Holidays: 25 (+12);
- Startdate: Asap;