Senior Material Operations Specialist – GMP/Cold Chain

Bristol Myers Squibb EU Policy; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb Leiden Cell Therapy Site is seeking a dynamic materials operations professional to join the team responsible for the management, movement and cleaning of materials across ambient and cold chain environments in a GMP setting.

You will execute routine and non-routine tasks, maintain safety and quality, and work with SAP/eWM to support internal and external customers. This role requires 8+ years in a cGMP warehouse and strong documentation skills.

Qualifications

• 8+ years of experience in a cGMP warehouse environment.
• DOT/IATA/HazMat experience and certifications a plus.
• Experience with 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.

Responsibilities

• Ensures routine activities such as receipt, storage, transfer, distribution, disposal and cleaning of all type of materials (ambient, cold chain, dangerous goods, etc.) as per GMP procedure.
• Prepares all type of material for shipment to internal and external parties, as per GMP procedure.
• Ensures materials are appropriately labelled in accordance with written GMP procedures.
• Perform inventory control practices including cycle counting and rejected/expired material disposition as described in the GMP procedure.
• Writes procedures to maintain a safe and organized working space.
• Performs inspection of incoming materials to the working area as per procedure.
• Uses material handling equipment - gas powered, electric and/or manual as per procedure.
• Handles materials based on Material Specifications i.e. temperature conditions, dangerous or hazardous conditions, etc. or as per procedure.
• Responds to system and equipment alarms during inside / outside office hours in rotating schedule as per GMP procedure.
• Facilitates ambient and cold chain sampling in collaboration with other department employees.
• Reviews GMP documentation and perform data verification.
• Coordinates internal and external customer requests across multiple unit operations during their shift to include personnel, material, and logistical needs.
• Puts away material into totes, or bags, and closes or seals them to prevent cross contamination, as per GMP procedure.
• Trains or facilitates the training of fellow associates on GMP Material Operations to ensure proficiency in all areas of operation.
• Proficiency in understanding and use of Quality Systems for Deviation, SOP revisions/creation, CAPA Management.
• Provides basic and first-line equipment troubleshooting.
• Acts as System champion and supports others in troubleshooting system issues (i.e., SAP, eWM, etc.).
• Owns assignment of Quality Event Change Actions.
• Creates, maintains and reports metrics to monitor departmental performance and data interpretation analysis with high reporting skills.
• Performs both routine and non-routine assignments and may help determine the appropriate approach for new assignments.

Tools

SAP

eWM

Job description

Bristol Myers Squibb Leiden Cell Therapy Site is seeking a dynamic materials operations professional to join the team responsible for the management, movement and cleaning of materials across ambient and cold chain environments in a GMP setting.

You will execute routine and non-routine tasks, maintain safety and quality, and work with SAP/eWM to support internal and external customers. This role requires 8+ years in a cGMP warehouse and strong documentation skills.