External Manufacturing Lead - Drug Product and Device
We are supporting a leading global organization seeking an experienced Contract Manufacturing Lead to oversee the operational management of global Contract Manufacturing Organizations (CMOs) and strategic vendors.
This role offers a dynamic blend of technical and business leadership, covering both early-phase pharmaceutical development and commercial operations. It’s an exciting opportunity for someone with strong expertise in drug product and device manufacturing, as well as experience leading teams and managing external partnerships.
This Role Will Offer You
* A strategic leadership position with significant global impact.
* The opportunity to manage and optimize external manufacturing operations.
* Exposure to cross-functional teams, driving projects from early-phase development through commercialization.
* The chance to lead key vendor relationships and ensure continuous product supply.
* A collaborative environment focused on operational excellence and continuous improvement.
Key Responsibilities
* Oversee the operational management of global CMOs and strategic vendors in drug product and device manufacturing.
* Act as the primary point of contact for external manufacturing partners, managing business operations and relationships.
* Manage projects from development through commercialization, including new product introductions and lifecycle improvements.
* Provide technical support for local and global manufacturing operations.
* Own and manage deviations, CAPAs, change controls, and technical documentation.
* Support process tech transfers, scale-ups, and validations at external sites.
* Foster a culture of collaboration, efficiency, and continuous improvement.
Who You Are
* Education: Master’s degree in a relevant field.
* Experience: 10+ years of significant operations management experience in a GMP environment, specifically in drug product and device manufacturing.
* Languages: Fluent in English, willingness to travel internationally.
* Expertise: Strong knowledge of pharmaceutical manufacturing, regulatory compliance, and process optimization.
* Leadership Skills: Proven ability to lead multi-functional teams and manage external business partnerships.
* Technical Knowledge: Deep understanding of pharmaceutical CMC and technology transfer to CMOs.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing, Science, and Production
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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