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 manufacturing and regulatory compliance
Required skills
Controlled substance recordkeeping, regulatory compliance, inventory management, hazardous material transportation, 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 APIs; Coordinate material supply and logistics including inter-site transfers and customs clearance; Administer reference standard and sample management programs; Ensure controlled substance compliance and accountability including physical security controls; Support regulatory licensing, reporting, and inspection readiness; Develop and maintain compliance systems and procedures.
Seniority
Mid-level, hands-on specialist