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CAR-T Specialist Full-time

at Johnson & Johnson Family of Companies in Pennsylvania (Published at 18-06-2019)

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Specialist, located in Malvern, PA.
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.
The CAR-T Specialist will:
  • Adapt supply strategies in view of changes in CAR-T trial execution and ensure a seamless transition from study design phase.
  • Support the development of CAR-T for Phase II/III
  • Utilize business tools to manage logistics at clinical sites and ensure on-time delivery.
  • Support the startup of CMOs for manufacturing of CAR-T
  • Support the manual tracking of Chain of Custody/Chain of Identity for subjects
  • Engage in the development and support the IT system for tracking of Chain of Custody/Chain of Identity at clinical sites and CMOs.
  • Manage the day-to-day Chain of Custody/Chain of Identity issues with clinical sites and CMOs
  • Manage and track inventory of labels for clinical sites.
  • Support the logistics of shipping to/from clinical sites and CMOs for CAR-T
  • Develop strong internal collaboration with GCDO stakeholders to ensure customer satisfaction.
  • Develop excellent working relationships with the other groups within Supply Management
  • With some guidance, responsible for managing all aspects of issue escalation and resolution at the study level.
  • Support business process improvement initiatives.
  • Responsible for the management of all clinical supplies during trial execution within J&J Pharma R&D (large and small molecules and for all phases of clinical trials).

Qualifications
  • A minimum of a bachelor?s degree (or equivalent experience) is required
  • A minimum of four (4) years of professional related business experience is required, preferably in a clinical supply related role
  • Experience with clinical trial operations, project management, pharma/bio research and development are preferred
  • Experience with clinical supply demand management tools (e.g. IVRS, SAP, OMP+) is preferred
  • Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint) is required
  • General knowledge of GxP principles is required
  • 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 are required
  • Ability to work in a high-pressure environment, acts with speed, flexibility, and accountability to achieve goals is required
  • This position will be located in Malvern, PA and may require up to 10% of travel

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.
Primary Location
United States-Pennsylvania-Malvern-
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Supplies
Requisition ID
6844190612


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