16 Sep
Sr. Manager - Cell Therapy Supply Chain
Vacancy expired!
- Global business process owner across all clinical sites for the following entities of cell therapy supply chain
- Accountability to align company, clinical site, and vendors to enable a seamless and short end-to-end patient flow
- Accountability to deliver the business process by collaborating with multiple stakeholders
- Internal: Clinical Sciences, Clinical Operations, Medical, GMP Operations, Quality Control, Quality Assurance, Biomarkers
- External: Clinical site, manufacturing, and logistics vendors
- Lead cross-functionally on planning, forecasting, prioritization, and escalation of patient material through patient journey to enable a short end-to-end time.
- Activate and manage patient registration and study flow in software platform.
- Coordinate leukapheresis and manufacturing slot allocation, sample shipment and logistics.
- Maintain accountability for chain of identity, custody and temperature deviations during shipments, support deviations and develop CAPAs.
- Interface with clinical operations to forecast patient infusions and align drug product delivery at the clinical site.
- Maintain accountability for adequate packaging inventory, customs documentation, and current import licenses.
- Manage third-party vendors, contract, budget, invoice, provide on call coverage for vendors critical to patient journey.
- Support clinical operations and CMC to enable new clinical site qualification and training for leukapheresis.
- Manage clinical site shipping qualification and training on most current SOPs for leukapheresis and drug product shipments.
- Build the pivotal/commercial model for operationalization of cell therapy
- Develop a process that is globally harmonized to provide oversight of n-IMP inventory at clinical sites.
- Bachelor's degree in Science, Engineering, or Supply chain is required
- Knowledge of cell therapy supply chain management is preferred
- At least 5 years of experience in biologics and pharma industry
- Knowledge of biologics logistics and distribution is a plus.
- Experience in your communication skills which will enable you to succeed in this cross functional matrix role
Vacancy expired!