Janssen Supply Chain is part of Janssen Supply Group, LLC, is recruiting for a Trial Supply Manager (1 of 2) to be based out of Malvern, PA or Titusville, NJ.
Janssen Supply Group, LLC, a global organization, whose mission is to deliver affordable medicines to anyone, anywhere any day. Our priorities are ground in our commitment to the safety of our people and in earning the trust of our customers and communities through the quality and reliability of our products. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The PDMS Clinical Supply Chain holds the global responsibility for all clinical supplies of the Janssen Research & Development portfolio and the Global Medical Affairs portfolio. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product, Packaged and Labeled Clinical Supplies), demand forecasting, supply planning, and global distribution of clinical supplies. Through a global network and organization (US, Switzerland, Belgium, Ireland, Netherlands, India), we are responsible for the manufacturing and scale-up of small and large molecules products in development and low volume commercial supply, and secure the supply to more than 60.000 patients in more than 330 clinical trials every year.
The Trial Supply Manager will be responsible for:
• Planning and inventory management of clinical supplies during the execution phase of clinical trials consistent with GCP guidelines
• Creating and executing supply strategies in view of changes in trial execution and ensuring a seamless transition from study design phase and assessing clinical study recruitment rates, forecasting for kit demand planning and ensuring supply planning is adopted accordingly
• Utilizing business tools to manage inventories at depots and sites and ensuring on-time delivery with minimal overage of clinical supplies, issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution) and establish and modify trial specific distribution agreements
• Participating as a member of appropriate GCDO clinical trial team, internal collaboration with GCDO stakeholders to ensure customer satisfaction, interfacing with Global Trial Managers.
• Developing excellent working relationships with the other groups within Supply Management
• Managing trial supply specific budget and supporting business process improvement initiatives and 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 is required
• A minimum of four (4) years of relevant experience is required
• Experience in a supply chain functional area (MAKE, SOURCE, PLAN, DELIVER) is required
• Experience in a clinical supply related role is preferred
• Experience using clinical supply demand management/planning tools (e.g., tcVisualize, IVRS, OMP+) or equivalent supply chain planning systems (SAP/ERP) is preferred
• Working knowledge and experience in S&OP processes is preferred
• Experience with the following functions: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management is preferred
• General knowledge of GMP or GCP principles are preferred
• Excellent written and verbal communication skills with the ability to communicate complex issues to internal and external stakeholders driving effective decision making is required
• Ability to manage inventory and determine need for material and capacity to address expected demand; ability to execute resulting plans
• Advanced skills with MS Excel (pivot tables, graphs, conditional formatting, etc.) is required
• Demonstrates awareness of pack/label and logistics operations and uses knowledge effectively planning and execution activities is preferred
• Ability to evaluate risks based on sound business analyses is preferred
• Ability to manage study specific budgets and communicate impact of changes is preferred
• Experience in managing complex projects is preferred
• This position is located in Malvern, PA or Titusville, NJ and could require up to 10% travel Primary Location
United States-Pennsylvania-MalvernOther Locations
North America-United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function