Materials Management and Controlled Substance Specialist
Core
Oversees the compliant lifecycle management and movement of development materials, including controlled substances, ensuring adherence to DEA and regulatory requirements.
Role type
Materials Management and Controlled Substance Specialist (Site Narcotic Substance Responsible person)
Builds
Secure, efficient, and compliant handling of APIs, controlled substances, and related materials for development and manufacturing activities
Domain
Pharmaceutical supply chain and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Controlled substance recordkeeping, regulatory compliance management, inventory control, hazardous material transportation coordination, reference standard management, cross-functional collaboration
Preferred skills
DOT and IATA shipping certification
Technologies
Microsoft Office
Responsibilities
Manage receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of raw materials and regulated substances; Coordinate material supply and logistics including inter-site transfers and customs clearance; Administer reference standard and sample management programs; Ensure controlled substance compliance through inventory management, reconciliation, and physical security controls; Support regulatory licensing, reporting, and inspection readiness; Develop and maintain compliance systems and procedures
Seniority
Mid-level, hands-on specialist