Supply Execution Team Lead
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Supply Execution Team Lead to work in either Horsham PA or Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create 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.
This people leader role is responsible for the team that manages clinical supplies during the execution phase of cell therapy clinical trials consistent with GMP guidelines with complete autonomy. This role is responsible for the management of all clinical supplies during trial execution within J&J Pharma R&D (for all phases of clinical trials) within Cell therapy.
Supply Execution Team Lead will:
· Develop and adapt supply strategies in view of changes in cell therapy trial execution and ensure a seamless transition from study design phase.
· Coach direct reports on daily activities, ensure the team and the Clinical Supply Chain maintains compliance to procedures and regulations regarding cell therapy clinical supply.
· Build and maintain excellent working relationship with key stakeholders across Clinical Supply Chain, commercial supply chain partners and clinical team members.
· Support the development of cell therapy clinical supply for Phase I / II / III and post-marketing studies.
· Be a process owner for the Chain of Custody/Chain of Identity process.
· Utilize business tools to manage logistics at clinical sites and ensure on-time delivery.
· Support the startup of CMOs for manufacturing of cell therapy.
· Support the manual tracking of Chain of Custody/Chain of Identity for subjects.
· Engage in the development and support the IT systems for automating steps of Chain of Custody/Chain of Identity at clinical sites, cryopreservation centers and manufacturing sites.
· Manage the day-to-day Chain of Custody/Chain of Identity issues with clinical sites and manufacturing sites.
· Manage and track inventory of labels for clinical sites.
· Support the logistics of shipping to/from clinical sites and CMOs for cell therapy.
· Exercise good GMP practices
· Develop strong internal collaboration with PDO and clinical team stakeholders to ensure customer satisfaction.
· Develop excellent working relationships with the other groups within Clinical Supply Chain
· Manage information in scheduling systems to manage subject journeys from apheresis to administration.
· Manage all aspects of issue escalation and resolution at the study level.
· Act as role model within team for use of core processes and proper use of systems and tools
· Takes accountability for own performance and development seeking opportunities to broaden knowledge and subject matter expertise.
· Support business process improvement initiatives.
•Leads SES team and provides coaching, guidance and input to help develop the team’s activities.
•E2E CSC accountability for V2V COC/COI tracking for subjects. Understands and leads strategic objectives of the organization and finds ways to implement these strategies in daily activities.
•Communication – Leads the SES team to setup/validate systems, and processes that result in information sharing, internal and external to the organization. Confidently presents controversial and/or complex information to all levels of the organization.
•Strategic Thinking - Leads strategic objectives for the CSC Clinical Supply Operations Oncology group and finds ways to implement these strategies in daily activities. Helps others understand and apply organizational objectives.
•Problem Solving / Decision Making - Leads impact assessment across the group for all issues/concerns.
•Project Management – leads in managing multiple, multifaceted and/or complex projects; manages expectations of stakeholders; analyzes risk management; oversees implementation of contingency plans, as appropriate.
•Cross functional Coordination - Uses a working network of relationships to achieve goals; participates with the team within own department or function, as well as across departments or functions.
• A university/bachelor’s degree (or equivalent experience) and 6-8 years of experience preferably in a clinical supply related role
• General knowledge of GxP principles
• Experience with the following functions preferred: clinical trial operations, project management, logistics, pharma/bio research and development.
• Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms.
• Strong planning and cross-functional coordination skills, able to build strong collaborative teams and relationships, leading cross functional/ virtual teams where required, contributes to employee engagement.
• Gathers diverse viewpoints and able to influence key stakeholders within the Clinical Supply Chain, and other key cross functional partners.
• Strong attention to detail
• Ability to work independently with limited coaching.
• Ability to multi-task and manage complexity.
• Ability to work in a high-pressure environment, acts with speed, flexibility, and accountability to achieve goals.
•Exceptional collaboration skills
•Integrity and Credo Based actions.
•Able to build and retain a diverse and inclusive team of staff and contractors.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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