A bit about us:
We bring together a breadth of technologies matched with deep knowledge of cancer-specific targets and TCRs to achieve the next advance in immunotherapy.Why join us?
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. We offer partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance.Job Details
- 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
2. PBMC intermediate from leukapheresis
3. Investigational Medicinal Product
4. Non- Investigational Medicinal Product (n-IMP)
- 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