1.Participate and contribute to the implementation of strategies and timelines to
ensure a successful clinical or commercial product launch, including oversight of
3PL/4PL, supply strategy, priority, and forecasting activities that impact overall
drug requirements.
2. Roll out serialization for commercial manufacturing to meet requirements and
implementation of strategies and timelines to ensure a successful clinical or commercial product launch, including oversight of 3PL/4PL, supply strategy, priority, and forecasting activities that impact overall drug requirements.
3. Roll out serialization for commercial manufacturing to meet requirements and
product traceability. Interface with CDMO, PMO, 3PL/4PL, Quality Assurance,
Regulatory Affairs, BioStats, Clinical teams, etc. to ensure timely implementation
of the requirements.
4. In partnership with CDMO teams, develop and implement secondary and tertiary
packaging solutions as well as shipping and transport qualifications in accordance
with applicable regulations.
5. Working with 3PL/4PL, Distribution, Marketing, and Sales Partners, ordering and
supplying drugs for the sites/CRO. Manage inventory of finished drug products.
6. Having excellent troubleshooting on any issues for completion/accuracy of the
product timeline. Logistics management globally including common and
emergency shipments of DSI/DS/DP/IP, and IRT system review for accuracy.
7. Develop commercial/clinical supply chain business processes, templates, and SOPs. Serve as a clinical supply subject matter expert for regulatory inspections. Contribute to INDs, NDAs, and other regulatory documents as needed.
8. Manage evaluation/selection/implementation/oversight of packaging, and labeling operations, development and management of distribution or supply agreements, interfacing between the CDMO and Clinical teams to ensure smooth conduct of clinical studies, coordination of import and export, etc.
9. To complete the assignment by supervisor.