Release & Stability Scientist QC

Release & Stability Scientist QC Location: Leiden, The Netherlands Function: Quality Control The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise. All test laboratories are supported by the Release & Stability team, which is integrated by product E2E QC owners who lead and coordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders (e.g. DPDS, PQM, VPAD, VCM, CMOs, EQ) and Leiden QC. The Release & Stability team leads and supports complex non-conformances investigations, initiates improvements to optimize the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC. Currently the Release & Stability team consists of 12 people and due to expansion of work load we are looking for new employees. Reporting Lines Supervisor: Manager Release and Stability Tasks and Responsibilities The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. Technical and job specific Fully owns end-to-end product testing process within Leiden QC independently Coordinates the release of raw materials drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.  Coordinates the stability testing of JSC large molecule products according to local procedures and agreed timelines.  Is a technical leader on biologics and/or vaccines release and stability testing processes and has a leading role during the GMP inspections. Participates in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience. Responsible to coordinate all data requests provided by various stakeholders (e.g. RA. Health Authority, DPDS) and has the accountability to plan, organize, prioritize and execute the data Requests based on the stakeholder requests. Responsible for reviewing the CPV plans and matrixes and update the QC release trend limits accordingly. Provide input for the YBPR and APR requests. Leads and drives continuous improvement projects. Influences, develops and executes strategy for expertise area. Trains and mentors colleagues in expertise area. Proactively shares knowledge with team and other sites and functions to drive improvement and alignment. Adhere to compliance best practices, EHSS regulations and lean principles. Perform other work-related activities assigned by supervisor. Maintain compliance with all company policies and procedures. Job interaction areas Internal: functional departments within the Quality organization, Value Chain Teams, regulatory compliance group, R&D (DPDS, VPAD), Product Quality Management PQM), External Quality, Quality Assurance (QA), Business Units, manufacturing sites within JSC, Global Planning. External: contract labs, CMOs. Qualifications Minimum Qualification Bachelor’s degree (or equivalent) in a relevant discipline with 6-8 years of related working experience. Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. Engages heavily in stakeholder management regarding projects, testing risks, successes and delays. Develops training material. Acknowledged expert on lab systems and lab environment, data integrity and data management. Acknowledged expert of statistical data analyses. Lean/BE experience. Proactive stakeholder management (within and between sites). Experience in project management and working according to GMP. Primary Location Netherlands-South Holland-Leiden- Organization Janssen Biologics (7266) Job Function Quality Requisition ID 2105977574W