External Manufacturing Senior Manager (DS/DP) job opportunity at Sobi.

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Date2026-03-20T14:33:42.417Z bot
Sobi External Manufacturing Senior Manager (DS/DP)
Experience: General
Pattern: Full-time
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loacation Raleigh, North Carolina, United States Of America
loacation Raleigh, North..........United States Of America
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Job DescriptionExternal 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 responsibilities:Team leader cross functional Virtual Plant Team (DS/DP) as applicableStrategic and operational CMO managementStrategic Partner ManagementSME in own fieldProcess ownerResponsible and main contact person for CMOs, leading Business Review and Operational MeetingsSupplier relationship management for CMO(s), ensuring e.g. supply agreements, change orders, improvements and OTIF deliveryParticipate in Sourcing evaluation of new contract manufacturers and developing supply and quality agreementsLead or participate in internal activities related to external manufacturing such as change management, major/critical deviations and CAPAsResponsible for maintaining and improving Primary (for Tabs & Caps) and Secondary packaging processes at CMosParticipate in tech transfer validation and manufacturing of DS/DP external manufacturers for Sobi projects in clinical and commercial phaseIssue, review and/or approve applicable external and internal SOP’s and manufacturing instructionsReview applicable sections of the APR/PQRBudget input and adherence for CMO/CLO related costsLead or participate in projects incl deviations investigations and CAPAsDriving continuous improvements to maintain efficient ways of working internally and at external network

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