J&J Family of Companies Supervisor HPLC team in Leiden, Netherlands

ONE JSC Stability Lab situated at the Janssen Biologics Manufacturing site in Leiden (The Netherlands) owns the stability programs of commercial biological products manufactured by the Janssen Supply Chain (JSC) such as Darzalex, Remicade, Stelara, Simponi, ReoPro and products in process validation for commercialization such as CNTO136, CNTO1959 etc. The services provided by the department also include release testing of biological drug substances and products. Currently approximately 40 employees are involved in the laboratory test activities and another 20 are involved the Lab services activities.

For the laboratory test activities the position of Team leaderis vacant for the HPLC team with 10 team members. Primary focus is day-to-day supervision and execution of daily tasks.

Responsibilities & Accountabilities:

The Teamleader is accountable for the personnel in the team, their performance and development. Accountable for effective team performance by setting objectives in line with the ONE JSC Lab Organization business cascade for direct reports.

The Teamleader keeps oversight and identifies the need for particular personnel.

The Teamleader leads and defined team execution testing activities that are compliant with the cGMP and safety regulations.

The Teamleader had the primary accountability for the planning, organization, day-to-day supervision and execution of daily tasks within the team and ensures the seamless transfer of activities.

The Teamleader assures that the assays are performed to the required quality and quantity as defined by planning, sets priorities in case of conflicting situations within the ONE JSC Lab Organization. Monitoring and reporting of all critical activities (e.g. process/delay of testing) to the manager. If necessary undertake actions independently.

The Teamleader deals appropriately with any deviations, OOT and OOS results and corresponding CAPAs on a defined team level and notifies involved ONE JSC Stability Lab management. Coordination of investigations on a defined team level to achieve resolution in the minimum time and in compliance with GMP principles. And is responsible for all first line trouble shooting on assay or equipment failure.

The Teamleader 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.

Qualifications

Profile:

• Education minimum relevant HBO diploma

• At least 5 years of work experience

• Good interpersonal and organizational skills

• Proven leadership potential

• Good communication skills

• Shown to have excellent safety and GMP awareness and experience

• A quality and compliance service minded attitude and flexibility

Primary Location

Netherlands-South Holland-Leiden

Organization

Janssen Biologics (7266)

Job Function

Quality Control

Requisition ID

1700179332W