Job Properties
  • Job Type
    Full-time Position
  • Background
    Engineering
    Other Science and Tech
  • Languages
    English
  • Experience Required
    10+ Years
  • Degree Required
    Bachelor
    • Province
      5,359 reviews
    • Date Posted
      January 15,2021
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    Principal scientist – Technical Launch Integrator New Products

    Technical Operations, being part of the Janssen Supply Chain and a member of Johnson & Johnson Family of companies, is currently looking for a

    Principal scientist – Technical Launch Integrator New Products

    in the Large Molecule Platform to be based in the Europe (Beerse;Leiden) with up to 30% travel.

    Position summary:

    The Technical Launch Integrator has overall accountability for ensuring fit for plant and commercial readiness of pharmaceutical processes and products into the supply chain and the global marketplace. Key responsibilities include Drug Substance (DS) and/or Drug Product (DP) technical support and oversight for the planning and execution of manufacturing site activities from tech transfer through commercial production. To fulfill the role the TLI is a member of several cross- functional teams.

    The TLI will support novel programs, such as cell & gene therapy programs, vaccine programs or sophisticated drug product tech transfer programs.

    In addition to the TLI role, this position may also support marketed products, as Drug Product Technical Owner (DPTO). The DPTO is the voice of Technical Operations in the Value Stream team and responsible for the technical aspect of the holistic Lifecycle Management structure and strategy of the product (for small and large molecules and both for new and legacy products).

    Principal responsibilities - TLI:

    • Technical and manufacturing integration of new and re-developed products from R&D into the supply chain (cell/gene therapy products, vaccines or any other large molecule products).
    • Leading the manufacturing site team and being the manufacturing site representative on the R&D team and the JSC Value Chain Team.
    • Single point of contact for Janssen Supply Chain (JSC) plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.
    • JSC technical input and technical acceptance into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards R&D and consistency across projects and across plants.
    • Contribution, review and approval of technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME’s) into project execution and QbD technical implementation at the manufacturing site level.

    Principal responsibilities - Product Technical Owner:

    • Represents Technical Operations and the technical team in the value stream team, leads the coordination of all product related technical activities and participates in development of long- term supply strategy including scenario development and E2E impact analysis.
    • Collaborates with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process).
    • Monitors technical process and product performance and supports failure investigations (escalation of quality or compliance events).
    • Executes or follows-up on execution of technical projects.
    • Understands the technical aspect of the lifecycle strategy of products.
    • Manages a multi-disciplinary team of technical specialists in the following areas : mfg site representatives, R&D, product stability, regulatory and Q&C.
    • Monitors technical process and product performance across internal and external mfg sites.

    Qualifications

    Profile:

    • Requirements: 8+ years of proven experience in pharmaceutical development or manufacturing; University or master's degree in pharmacy, chemistry, engineering or related area
    • Experience in cell and gene therapy manufacturing processing and/or vaccine manufacturing
    • Knowledge of Regulatory guidance related to biologics, cell and gene therapy, aseptic processing, validation, cGMP, and combination products
    • Experience with late stage development and introduction of pharmaceutical products to manufacturing sites
    • Planning and logistics skills capable of effective integration of deliverables and support detailed execution at the manufacturing site level.
    • Knowledge of manufacturing site systems and procedures (SAP, complaint handling, change control, qualification, process validation and Continued Process Verification, … etc.)
    • Good knowledge of EHS, Q&C, and regulatory requirements/GMP.
    • Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.
    • Project management skills (FPX or similar), project planning, structuring, organizing, coordinating teams, and setting up and maintaining communication with stakeholders and wider network organization;
    • Excellent written and oral communication skills and ability to influence peers, superiors, and partners.
    • Motivated, able to work independently with demonstrated problem solving skill
    • Proficiency in English (spoken and written) is a requirement, knowledge of the Dutch language is an added value.

    We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.

    If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the posting period, please send in your application as soon as possible.


    Primary Location
    Belgium-Antwerp-Beerse-
    Other Locations
    Netherlands-South Holland-Leiden
    Organization
    Janssen Pharmaceutica N.V. (7555)
    Job Function
    Operations
    Requisition ID
    2005882240W
     
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