Senior GMP Material & Cold-Chain Operations Specialist

Qabird; Leiden; On-site; EUR 70,000 - 95,000; Full time

Job summary

Leiden Cell Therapy Site at Bristol Myers Squibb Netherlands seeks a dynamic Lead Material Operations Specialist II to manage routine material movements, cleansing and storage while complying with GMP. You will coordinate inventory, labeling, and cycle counts, ensuring safe handling of ambient and cold chain materials for internal and external customers.

The role requires strong procedural writing, project management, and cross-functional collaboration, with extensive experience in SAP/eWM and

Qualifications

• 8+ years of experience in a cGMP warehouse environment and understanding of Materials Management.
• DOT/IATA/HazMat experience and certifications a plus.
• Experience with receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition.
• Experience in cold chain logistical movement of time critical and temperature sensitive biologics.
• Knowledge of Freight forwarder and courier direct shipments and associated documentation requirements is preferred.
• Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments is required.
• Understanding of physical cold chain requirements supporting the logistical movement of time critical and temperature sensitive biological material is required.
• Ability to define and write procedures.
• Reliable and detail oriented with organizational skills.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Ability to work in a fast-paced team environment, meet deadlines and changing priorities.
• Operation of basic warehouse equipment (i.e. forklift, pallet stacker, etc.) is required.
• Advanced experience with SAP system usage or any other Warehouse ERP system is required.
• Experience with project management is required.
• Demonstrated technical writing skills experience.

Responsibilities

• Receives, stores, transfers, distributes, disposes and cleans all material types as per GMP procedures.
• Prepares materials for shipment to internal and external parties as per GMP procedures.
• Ensures materials are properly labelled in accordance with GMP procedures.
• Performs inventory control practices including cycle counting and disposition of rejected/expired material.
• Writes procedures to maintain a safe and organized working space.
• Inspects incoming materials to the working area as per procedure.
• Operates material handling equipment per procedure.
• Handles materials according to temperature conditions and safety requirements.
• Supports equipment commissioning activities as requested.
• Responds to system and equipment alarms during shifts as per GMP procedure.
• Facilitates ambient and cold chain sampling with other departments.
• Reviews GMP documentation and performs data verification.
• Coordinates internal/external requests across multiple unit operations.
• Stores materials into totes/bags and ensures containment to prevent cross contamination.
• Trains or facilitates GMP Material Operations training for associates.
• Supports Quality Event Change Actions and data reporting.
• Creates and maintains metrics to monitor departmental performance.
• Performs routine and non-routine assignments and helps determine approaches for new work.
• Owns assignment of quality actions.

Skills

Quality systems understanding

Communication skills

Detail-oriented

Project management

Team collaboration

Procedural writing

Problem solving

Safety awareness

Tools

SAP

eWM

Warehouse ERP

Forklift operation

Job description

Leiden Cell Therapy Site at Bristol Myers Squibb Netherlands seeks a dynamic Lead Material Operations Specialist II to manage routine material movements, cleansing and storage while complying with GMP. You will coordinate inventory, labeling, and cycle counts, ensuring safe handling of ambient and cold chain materials for internal and external customers.

The role requires strong procedural writing, project management, and cross-functional collaboration, with extensive experience in SAP/eWM and