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Device & Packaging, Technical Launch Integrator
il y a 2 semaines
Primary Container & Device, Technical Launch Integrator in
Beerse, Belgium
You will be a member of a global team located across the US, Switzerland and Belgium.
Device and Packaging solutions are becoming a more important component in delivering innovative medicines to our patients. We are looking for a team member who combines technical expertise with project leadership. Together we strive to bring the best possible product and process to a successful new product launch.
You will work in the New Product Introduction (NPI) team, part of the Primary Container & Device, Large Molecule team.
This team owns the technical transfer of newly developed products from Janssen R&D to Janssen Commercial Supply Chain (JSC).Key Responsibilities:
Project Leadership and Technical Launch Management
- Lead complex global and local project teams; you are a core team member in the value chain team and the supply chain development team.
- Partner with the drug product and drug substance to ensure a single JSC technical voice at the right partner table.
- Provide regular updates to project collaborators and sponsors through regular reports, presentations, and adhoc communication.
- Ensure that all technical deliverables for health authority submissions and launch readiness are completed ontime and with the right quality.
- Provide up to 1 year of postlaunch support to ensure manufacturing stabilization and fluent transfer of ownership to base business.
Device & Packaging Technical Transfer:
- Work with the Primary Container & Device development team (PCD) to optimize design of device and primary container for commercial assembly, packaging, and distribution.
- Work with internal partners and suppliers to search for the best possible offtheshelf and custom designed device components and secondary packaging materials solutions.
- Integrate customer insights, standard platforms, and requirements from various partners in Research & Development (R&D), the global Janssen Supply Chain organization and the production site.
- Ensure accurate specifications and adequate controls are in place.
- Drive development, implementation, and validation of the device assembly and packaging processes at commercial scale and according to best practices and standard procedures.
- Partner with project engineers to ensure that assembly and packaging equipment is accurately designed, tested, installed, and qualified.
- Deliver a robust tech transfer documentation set inline with applicable combination product and packaging design transfer procedures. This includes a design transfer plan and report, control strategy, FMEA, equipment qualification and process validation, distribution testing, procedures, protocols, adhoc test protocols, data analysis and summary reports.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Qualifications:
Required:
- Experience in device and packaging operations, engineering, project management and/or R&D
- Experience working in the pharmaceutical, medical device or fastpaced consumer goods industry
- Experience leading projects from initiation to completion with a multifunctional team in a global context
- Past experience working with 3rd party vendors
- Travel 25% domestic & international based on project and business needs
- Ability to work at Beerse, Belgium location.
Preferred:
- Bachelor's Degree or advanced in engineering or science field
- Experience with Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management, Qualification, Verification and Validation
- Experience with primary containers; vials, syringes, cartridges
- Experience with advanced therapies; radiopharmaceuticals, cell and gene therapy
- PMP/FPX project management certification
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