Temperature Management Lead

Job content

Janssen Research & Development, part of the Johnson & Johnson Family of Companies, is recruiting for a Temperature Management Lead within the Clinical Supply Chain (CSC). At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us! We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. CSC holds the global responsibility of all clinical supplies (API, Drug Product, Packaged and Labeled Kits) in the R&D portfolio. Our activities include all in-house and outsourced manufacturing, demand forecasting, supply planning, and global distribution of supplies to more than 145,000 patients in over 85 countries in more than 400 clinical trials every year. Are you ready to make a positive impact on patients? I’m ready for you to join my team! Objectives and Responsibilities Within CSC, the Temperature Management & Control (TM&C) Team is responsible for the management of clinical supplies (Drug Product and Finished Kits) within Janssen R&D (biotherapeutics, vaccines, and small molecules) during all phases of clinical trials consistent with Good Manufacturing, Distribution, and Clinical Practices (i.e. GxP guidelines) with a specific focus on Temperature Management & Control (TM&C). Key Responsibilities: The TM&C Lead is a matrix leader who does the following: Acts as Lead TM&C Spokesperson for audits and inspections. Is a subject matter authority on TM&C processes. Coaches the TOR (Temperature Out of Range) Team, which handles all temperature excursions associated to clinical supplies during trial feasibility and throughout trial execution for all phases of clinical trials. The TM&C Lead acts as the first point of escalation in case of issues and ensures critical coverage when necessary. Drives prompt resolution and compliance with SOP, GxP, Quality, and Regulatory guidelines, positively influencing Successful Patient Dosing. Identifies and leads the implementation of strategy for TM&C metrics, processes, and systems. Builds capabilities of the TM&C team by documenting and sharing lessons learned. Develops strong internal collaboration with the broader CSC organization (i.e. Clinical Supply Integrator, Trial & Supply Management, Logistics), and cross-functional business partners (i.e. Global Clinical Operations, Drug Product Development, Analytical Development, Quality) to execute temperature management processes. Qualifications Qualifications: Required: A minimum of a university/bachelor’s degree (or equivalent). 6+ years of professional-related business experience. Must demonstrate exceptional collaboration and teamwork skills. Experience with GxP principles, audits, and inspections. Experience in at least one of the following areas: clinical supply chain, supply chain operations, planning, logistics, quality, regulatory, pharmaceuticals research & development. Highly organized with strong attention to detail A situationally appropriate sense of urgency with the ability to drive resolution with minimal management oversight Ability to work effectively and with limited coaching in a dynamic environment, multi-task, and handle complexity across daily planned and unplanned operational activities Excellent written and verbal communication skills, able to communicate clearly and make complexity clear and understandable across all levels of the organization. Must be process-oriented and solution-focused and must show resiliency in a dynamic environment. Preferred: GxP inspection/audit spokesperson experience is highly preferred. Understanding of pharmaceuticals temperature management (during storage and distribution) is highly preferred. Project management experience FPX, APICS, PMP, Lean/Process Excellence certifications Experience in one or more of the following areas: clinical supply related role (i.e. operations, logistics, quality, planning, development), clinical operations, pharmaceuticals logistics, pharmaceuticals planning, quality & compliance Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105950908W