Senior Manager QC Stability, NPI and New Technology

Janssen Biologics is currently recruiting a Senior Manager Quality Control, Stability, New Product Introduction (NPI) & New Technology within our Quality department. The successful candidate needs to have QC testing and manager leadership experience in the biologics/pharmaceutical/manufacturing industry with a relevant educational background.

About the Company:

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, dedicated and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.

Within the QC laboratories of the Janssen Supply Chain the Leiden QC LM laboratory is responsible for the release, stability testing of intermediate and final products (monoclonal antibodies and vaccines). Leiden QC is uniquely positioned as the HUB for Large Molecule Stability testing. It represents various combined test labs classified based on specific techniques and / or expertise. The test labs are supported by the Stability, NPI and New Technology Team that offers a broad range of services for Product Stability Testing, New Product Introduction and New Technologies for the QC testing.

As a Sr manager of this department, you will lead with credo principles at hand ensuring of the diversity and inclusion of the team shaping, simplifying, and innovating the support to the internal QC laboratories and directly involved stakeholders in R&D, Product Development and Analytical Development. You are accountable for the flawless introduction of the QC testing for New Products within the department and/or External Contract Labs. New Product Introduction involves all aspects of method transfers and ensuring that associated resource requirements are translated into the budget cycle. You are also responsible for coordinating stability programs and internal and external scouting of new technologies to prepare the department for the future. You will be part of the QC Management team working on successes for today, tomorrow and the day after tomorrow fostering connected people, connecting things.

The responsibilities & the impact YOU will have:

• Leading the teams responsible for New Product Introduction, Stability Testing and New Technologies and Environment, Health, Safety and Sustainability (EHS&S) of Leiden QC.
• Support the broader organization/business with knowledge of the product stability of JSC Large Molecule products
• Support the broader organization/business by providing governance via the Large Molecule stability committee to the stability programs in the different development phases of the product.
• Responsible for managing the NPI activities with the QC technicians engaged in transferring primary and secondary analytical method and technology transfers to ensure compliance with quality standards.
• Accountable for the performance and act as a Servant Leader to coach and develop team members to become successful in talent development and business performance.
• Acting as change agent and build and maintain team capabilities to meet current and future needs
• Setting goals and objectives for the department and define Key Performance Indicators that are indicative for excellent performance.
• Achieving innovation and excellence in business processes
• Ensuring that procedures and guidelines linked to safety, environmental and health are met.
• Ensuring that overall compliance to regulatory cGMP requirements, global standards, procedures, etc.