CLS Services

Gepubliceerd: about 2 months ago

Supervisor Bioassay team

Leiden
Gepubliceerd: about 2 months ago
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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 a Supervisor Bioassay team.

Company profile
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.

Department
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 all analytical test methods using various bioactivity and identity techniques, ranging from early clinical up to commercial process control, release and stability.

Job description
Do you have demonstrable supervisory experience within Pharma or another strongly regulated industry? Do you have GMP knowledge and excellent communication skills? Then this position might be the one for you!

For the Bioassay team, we are looking for a Supervisor that will lead the team and ensure the day-to-day operations of the team. Your key responsibilities are:

  • Lead 8-12 lab technicians and are 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 Organisation business strategy;
  • Lead and define team execution testing activities that are compliant with the cGMP and safety regulations. Furthermore, you assure 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;
  • You have the primary accountability for planning, organisation, day-to-day supervision and execution of daily tasks within the team and ensure the seamless transfer of activities using SmartQC;
  • Assure that the assays are performed to the required quality and quantity and set priorities in case of conflicting situations within the ONE JSC Lab Organisation. You oversee all monitoring and reporting of all critical activities (e.g. process/delay of testing). If necessary, undertake actions independently and assure relevant action plan is in place (e.g. earned hours etc.);
  • Deal appropriately with any deviations, OOT/ OOS results corresponding CAPAs and Change controls on a defined team level and notify involved ONE JSC Lab management. You will be responsible for closure of all low impact deviations. Additionally, you ensure the proper co-ordination of investigations on a defined team level to achieve resolution in the minimum time and in compliance with GMP principles;
  • You are 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;
  • You are responsible for creating team environment for continuous improvements applying the Business Excellence and Faster Forward tools.


Who we're looking for
The ideal candidate has a B.Sc. or M.Sc. in a relevant field with several years of relevant work experience and with supervising a team. As you will be closely collaborating with two other Supervisors, you must have good co-ordination and interpersonal skills and be able to keep a good overview of work, as lots of things can happen at the same time. We are looking for someone with GMP knowledge and a quality, compliance and business minded attitude.

Additional vacancy information
Reference: A2000044
Contract: Temporary contract with CLS Services
Education: WO/MSc.
HBO/BSc.
Terms: Project for at least 1 year. Longer-term could be possible depending on business factors, but no promises can be made at this stage
Full time preferred, 32 hours discussable.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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Vacature details

Fulltime / parttime

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