Director, E2e Clinical Supply Planning
il y a 2 semaines
At Janssen Pharmaceutics, everyone is committed to make a difference in people's lives and to push the boundaries of what science and innovation can achieve.
Put simply, Our Credo challenges us to put the needs and well-being of the people we serve first, our patients, doctors and nurses, our employees, our communities and our partners.
Together with our colleagues all over the world, all with a heart for the patient, we strive for a future in which disease is a thing of the past.
The Role
Within Therapeutics Development & Supply, the Clinical Supply Chain organization has an open position for a Director End-to-End (E2E) Supply Planning.
Clinical Supply Chain (CSC) holds the responsibility of global 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 supplies.
Through a global network and organization (US, Switzerland, Belgium, Ireland, Netherlands, India, China), we are responsible for the clinical supplies of Small Molecules and Bio Therapeutics products in development and low volume commercial supply and secure the supply to more than patients in more than 330 clinical trials every year.
As Director End-to-End Supply Planning you will be responsible, together with your team to drive the optimal planning of the clinical supplies from an end-to-end perspective across all dimensions of the clinical supply chain.
You will drive the planning during the study execution phase of pharma R&D clinical trials, covering Small Molecules, Protein Therapeutics, Cell Therapy and RnA & Gene Therapies.
The Supply Planning team is focused on developing the unconstrained end-to-end supply plan to ensure Successful Patient Dosing.Partnering and closely collaborating with development scientists, Pilot Plants, External Supply Integration, the Janssen Supply Chain and Contract Manufacturing Organizations (CMO) will be key to success.
You are accountable for preparing and leading the E2E Meetings and the Integrated Demand & Supply Meetings, including escalation topics at the Executive S&OP level (CSC Council).
- Shaping and development of the E2E planning process for Advanced Therapies ( eg CAR-T)
- Shaping, developing and creating full E2E visibility on the supply plan by identify the underlying assumptions for Kit/DP/API supply plan and reinforcing the cS&OP process
- Leading a team of E2E Supply Planners, responsible for
- Developing optimal endtoend drug product and drug substance supply strategies for a compound that minimize waste while meeting the timelines and needs of the Clinical Trial Material supply plans.
- Creating drug product and drug substance supply plans by aggregating clinical demand across different trials as well as nonclinical demands, to ensure timely delivery, testing and release of clinical batches.
- Providing information to the Supply Network Capacity Planners and Plant Schedulers to allow constrained master and/or detailed scheduling of batches in the CSC supply network in line with the trial requirements and in line with critical raw material and component availability.
- Ensuring portfolio timelines and business performance goals, objectives and metrics are achieved, including consistency with GMP guidelines and all other compliance requirements
- Leading and/or supporting crossfunctional and crossdepartmental initiatives to improve business process/tools
- Leading and developing the team as well implementing department and functional strategy
Qualifications:
Who we're looking for:
- You acquired a Master's degree or equal to experience and have a strong record of supply chain and planning experience. Experience in a pharma environment (GxP) and APICS/Lean certification is a plus.
- You have a passion for utilizing advanced planning and scheduling tools (OMP) and ERP Systems (SAP).
- You have an innate aim to make the difference and achieve results. Your continuous improvement attitude and innovative thinking will help you to see opportunities and related business needs.
- We expect decisiveness, brainpower and dealing with various issues and projects simultaneously.
- We expect strong collaboration skills with internal and external partners
- Adaptiveness to constantly evolving organization issues, structures, and dynamics is a must have
- You are a selfstarter that can work independently and handle inputs from diverse business partners and stakeholders.
- Your communication and negotiation skills are excellent, with ability to communicate clearly and appropriately to all levels of the organization in both written & oral forms.
- You are able
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