Job Properties
  • Job Type
    Full-time Position
  • Background
    Biotech and Agricultural
    Engineering
    Management & Business Others
    Medical and Healthcare
    Other Science and Tech
  • Languages
    English
  • Experience Required
    3 - 5 Years
  • Degree Required
    Bachelor
    • Province
      5,424 reviews
    • Date Posted
      May 21,2021
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
    • CV CHECK
    • internship package

    Release & Stability Manager QC

    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.

    Goal of the function/Primary objective of the Job

    Responsible for managing and coordinating the Stability & Release team, which is composed of several experts and scientists engaged in commercial products Life Cycle Management, issues management and resolution, and several improvements projects.

    Reporting Lines

    • Supervisor: Sr Manager Stability, NPI and New Technologies
    • Direct reports: 6-8 Scientist/Experts plus contractors

    Tasks and Responsibilities

    Technical and job specific

    • Ensures release and stability testing processes are robust and standard to ensure compliant, efficient and on-time testing.
    • Secures budget and resources for commercial products support for the department.
    • Supports the department with being an expert on stability and E2E release testing of JSC Large Molecules
    • 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 local procedures and agreed timelines.
    • Proactively partners with stakeholders to position the Leiden QC department as large molecule stability hub and CMO release testing for commercial products.
    • Manages Life Cycle Management projects and requests for commercial products.
    • Ensure the team is subject matter expert on release and stability processes and has a leading role during the GMP inspections and throughout the LCM of the commercial products
    • Maintains oversights over the implementation of guidelines, regulations and global standards related to stability management and execution.
    • Reviews stability protocols, release Certificate of Analysis and Quality Agreements/ SLAs with multiple customers.
    • Participate in management meetings, joins the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM, External Quality) and other testing sites to ensure flawless experience and network alignment
    • Represents Leiden QC in escalation and senior management platforms in relation to release or stability testing escalations, strategy, and improvements

    Managerial

    • Mentors, coaches, trains, and develops the personnel of the team. Evaluates performance and provides opportunities for growth.
    • Manages the planning and resource allocations of the team
    • Manages the development and implementation of metrics to measure and improve performance
    • Secures resources and budget for commercial release and stability testing within Leiden QC
    • Creates a team environment for continuous improvements and critical and creative thinking

    Compliance, Quality, Safety and Health

    • Ensure that procedures and guidelines linked to safety and health are met
    • Ensure that the group complies with the environmental procedures and guidelines
    • Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.
    • Ensure that data are generated and maintained according to current regulatory requirements

    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


    Profile needed for this function

    Education / Qualification

    • Master degree in chemistry & biotechnology or equivalent by experience with 8-10 years’ experience in the pharmaceutical industry.

    Professional experience

    • Experience in Quality Control, Method development, validation, etc.
    • Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)
    • General knowledge of pharmaceutical development & manufacturing
    • Experience in other supply chain functions is an asset (e.g. Operations, Quality, Planning)
    • Organizational planning and problem-solving experience
    • Strong leadership & development qualities
    • Experience with principles of Process Excellence, Lean manufacturing, etc.
    • Good presentation skills
    • Excellent knowledge of English
    • Experience in managing people (direct report lines, or indirect e.g. projects)

    Primary Location
    Netherlands-South Holland-Leiden-
    Organization
    Janssen Biologics (7266)
    Job Function
    Quality
    Requisition ID
    2105935790W
     
    Open Positions from Johnson & Johnson Family of Companies
    Related positions