MS&T Raw Materials and Validation Lead – Associate Director - Dunboyne
Core
Lead methodology and governance for process, cleaning, and shipping validation, and manage raw material strategies for biologics drug substance manufacturing.
Role type
Associate Director, Validation & Raw Materials Lead
Builds
Reliable, compliant, and efficient biologics manufacturing operations
Domain
Biologics / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics manufacturing, Cleaning validation, Process validation, Raw material management, Risk management, Deviation management, Change control, Cross-functional collaboration, Regulatory compliance, Continuous improvement
Preferred skills
Shipping validation
Technologies
None stated
Responsibilities
Serve as site subject matter expert for process, cleaning, and shipping validation; Lead site-wide cleaning validation strategy; Provide technical oversight for raw material selection and lifecycle management; Lead or support investigations related to raw materials and supplier changes; Ensure validation activities remain inspection-ready; Collaborate to ensure drug substance supply continuity; Identify opportunities to improve validation programs and operational efficiency.
Seniority
Associate Director, hands-on technical leadership