Duties: Optimize package designs, and manage contracted activities to assure delivery of on time, quality clinical finished goods (Ph I-IV) packaged according to GMP, through effective supplier relationship and performance management. These activities are performed with DSM approved contractors, in cooperation with Quality Assurance and other line functions.
1. Primary liaison with contractors for external packaging and distribution campaigns
2. Manages all finance activities, including Request for Proposal (RFP) for bidding & vendor selection, Grants, Purchase Orders (PO) and invoice approval
3. Manage all packaging activities, including Work Order (WO) creation, review & approval of contractor packaging records and monitoring in-process / on-going work at contractors with limited supervision
4. Packaging design optimization; works with SP&D to advise on and challenge protocol aspects related to average packaging design
5. Initiates audits and participates in audits together with GMP QA and GCP QA (where applicable) to assess contractor capabilities
6. Organizes and coordinates the shipment of drug product and packaging material to contractors
7. Responsible for materials and inventory management of all drug product, components and labels at the contractors.
8. Establishes and manages supply related timelines with other groups as SP&D, QA, PHAD, to ensure agreed timelines are met
9. Authorizes destruction of outdated material
10. Contribute to/lead process improvement activities within Global DSM and TPO
11. Establishes contact network with client approved contractors and vendors
Skills:
1. At least 2 years of relevant experience in Pharmaceutical Development, Clinical Development, Clinical Supply Operations, Project Management or Related Field.
2. Intermediate organization, planning and leadership skills.
3. Intermediate communication, negotiation and interpersonal skills.
4. Ability to strategically plan, organize and manage multiple projects simultaneously.
5. Demonstrates track record of creativity and problem solving in projects.
6. Demonstrates working knowledge of clinical supply systems and specialized tools.
7. Intermediate knowledge of development activities and processes.
8. Intermediate project management skills.
9. Intermediate presentation skills.
10. Ability to work in interdisciplinary teams.
11. Knowledge of relevant GMPs and company policies as well as applicable multinational regulations.
Education:
Minimum: Degree in scientific or relevant discipline (MS or equivalent)
Desirable: Advanced degree in scientific or relevant discipline