تم وضع المناقشة في: غيرها في فيرمونت | علق: |
Job Description
External DS/DP Manufacturing is part of External Manufacturing Operations & SRM. External Manufacturing Operations & SRM is responsible for operational oversight of clinical-and commercial- external manufacturing of Drug Substance, Drug Product and Finished Goods (Including IMP Supply) for Sobi projects and products world-wide.
The responsibility includes providing leadership and operational excellence of compliant manufacturing and overseeing the management and delivery from external CMOs and CLOs, that can meet global health authority requirements and Sobi needs today and in the future.
Key Responsibitilies
Team leader cross functional Virtual Plant Team (DS, DP, CLO as applicable)
Strategic and operational CMO management:
Responsible and main contact person for CMOs, leading Business Review and Operational Meetings or provide CMO Management input to partner BRM/JMSC.
Supplier relationship management for CMO(s), ensuring e.g. supply agreements, change orders, improvements and OTIF delivery
Participate in Sourcing evaluation of new contract manufacturers and developing supply and quality agreements
Lead or participate in internal activities related to external manufacturing such as change management, major/critical deviations and CAPAs
Participate in tech transfer, scale up, validation and manufacturing of DS and DP processes at external manufacturers for Sobi projects in clinical and commercial phase
Issue, review and/or approve applicable external and internal SOP’s
Review applicable sections of the APR/PQR
Budget input and adherence for CMO/CLO related costs
Lead or participate in projects
Driving continuous improvements in order to maintain efficient ways of working internally and at external network.