Johnson & Johnson Innovative Medicine
Primary Container & Device Technical Launch Integrator
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Primary Container & Device Technical Launch Integrator
Johnson & Johnson Innovative Medicine invites an experienced professional to join our Global Team as a Primary Container & Device Technical Launch Integrator. The role is based in Titusville, New Jersey, with hybrid participation across the US, Switzerland, and Belgium. The integrator combines technical expertise with project leadership to deliver the best possible product and process to a successful new product launch.
Job Location Titusville, New Jersey, United States of America. Hybrid position can be based in Titusville, New Jersey.
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 supply chain technical voice at the right partner table.
Provide regular updates to project collaborators and sponsors through regular reports, presentations, and ad‑hoc communication.
Ensure that all technical deliverables for health authority submissions and launch readiness are completed on‑time and with the right quality.
Provide post‑launch 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 off‑the‑shelf 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 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 in‑line 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, ad‑hoc test protocols, data analysis and summary reports.
Qualifications Education
Bachelor's Degree in Engineering or scientific field.
Required
Minimum of 5 years in device and packaging operations, engineering, project management and/or R&D.
Experience with advanced therapies; radiopharmaceuticals, cell and gene therapy.
Project Management experience.
Experience working in the pharmaceutical, medical device or fast‑paced consumer goods industry.
Experience leading projects from initiation to completion with a multi‑functional team in a global context.
Ability to achieve challenging goals and solve complex problems.
Excellent communication and ability to effectively drive, contribute and influence in different global & virtual teams through appropriate means of communication.
Past experience working with 3rd party vendors.
Ability to build, and lead global complex cross‑functional teams.
Travel 25% domestic & international based on project and business needs.
Preferred
Advanced Degree.
Experience with Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management, Qualification, Verification and Validation.
Experience with primary containers; vials, syringes, cartridges, freeze bags.
PMP/FPX project management certification.
Benefits The anticipated range for this position is 91,000-147,200.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Job Location Titusville, New Jersey, United States of America. Hybrid position can be based in Titusville, New Jersey.
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 supply chain technical voice at the right partner table.
Provide regular updates to project collaborators and sponsors through regular reports, presentations, and ad‑hoc communication.
Ensure that all technical deliverables for health authority submissions and launch readiness are completed on‑time and with the right quality.
Provide post‑launch 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 off‑the‑shelf 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 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 in‑line 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, ad‑hoc test protocols, data analysis and summary reports.
Qualifications Education
Bachelor's Degree in Engineering or scientific field.
Required
Minimum of 5 years in device and packaging operations, engineering, project management and/or R&D.
Experience with advanced therapies; radiopharmaceuticals, cell and gene therapy.
Project Management experience.
Experience working in the pharmaceutical, medical device or fast‑paced consumer goods industry.
Experience leading projects from initiation to completion with a multi‑functional team in a global context.
Ability to achieve challenging goals and solve complex problems.
Excellent communication and ability to effectively drive, contribute and influence in different global & virtual teams through appropriate means of communication.
Past experience working with 3rd party vendors.
Ability to build, and lead global complex cross‑functional teams.
Travel 25% domestic & international based on project and business needs.
Preferred
Advanced Degree.
Experience with Design Control, Design Transfer, Purchasing Control, Change Control, Risk Management, Qualification, Verification and Validation.
Experience with primary containers; vials, syringes, cartridges, freeze bags.
PMP/FPX project management certification.
Benefits The anticipated range for this position is 91,000-147,200.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr