Adicet Bio, Inc
GMP Materials Management and Supply Chain Specialist
Adicet Bio, Inc, Redwood City, California, United States, 94061
GMP Materials Management And Supply Chain Specialist
We are seeking a motivated and detail-oriented GMP Materials Management And Supply Chain Specialist to support manufacturing, quality, and safety goals, ensuring seamless GMP operations. Reporting to the Senior Manager, GMP Materials Management And Supply Chain, this role is responsible for the receipt, release, kitting, inventory control, and shipment of GMP materials, as well as supporting development teams with timely and accurate supply chain operations. The ideal candidate will have experience in GMP materials management and warehouse operations, strong organizational skills, and the ability to thrive in a fast-paced, collaborative biotech environment. Responsibilities Shipping & Receiving Perform receiving operations for both incoming materials and finished products. Schedule, prepare, and monitor shipments of final or intermediate products in compliance with GMP SOPs. Coordinate cold chain shipments from Adicet, ensuring proper packaging, documentation, and temperature control. Facilitate communications and address questions/concerns raised by partners such as clinical storage depots, distribution depots, and couriers Collaborate with domestic depot and international depots to provide oversight for international drug supply shipments including creation of commercial invoices and ensuring all documents needed by courier and importer of record are established Materials & Inventory Management Receive, inspect, release, and stock GMP materials, including cleanroom gowning, cleaning, and disinfection supplies. Prepare and kit materials for manufacturing in a timely and accurate manner. Maintain inventory management systems in compliance with standard warehouse practices (barcoding, FIFO, reorder triggers, manufacturing fill orders, etc.). Monitor inventory and generate reports on quantities, lot status, and expiration dates for stakeholders. Investigate and resolve inventory discrepancies promptly. Collaborate with QA on the disposition of GMP raw materials. Compliance & Continuous Improvement Ensure compliance with GMP, GDP, and applicable federal, state, and local regulations. Create, revise, and maintain SOPs related to materials management and supply chain processes. Drive continuous improvement in supply movement, warehouse optimization, and kitting processes. Complete day-to-day materials management tasks to ensure timely completion. Follow all safety procedures and support a culture of quality and compliance. Qualifications 24 years of relevant GMP materials management, supply chain, or warehouse/distribution experience in the pharmaceutical or biotech industry (experience level determines title). In-depth knowledge of pharmaceutical product shipment and warehouse operations in a GMP environment. Working knowledge of GMP, GDP, GCP, and relevant FDA guidelines. Technical skills in materials management with the ability to handle multiple priorities. Experience with international shipping logistics including generation of pro-forma and commercial invoices Understanding of import/export requirements including incoterms and importer of record roles Experience with cryogenic cold chain handling in a biopharmaceutical setting. Strong process orientation and attention to detail. Excellent verbal and written communication skills; able to collaborate across all levels of the organization. Highly self-motivated, adaptable to changing priorities, and comfortable in a fast-paced, small-company setting. Proficiency with MS Word, Excel, PowerPoint, and Outlook.
We are seeking a motivated and detail-oriented GMP Materials Management And Supply Chain Specialist to support manufacturing, quality, and safety goals, ensuring seamless GMP operations. Reporting to the Senior Manager, GMP Materials Management And Supply Chain, this role is responsible for the receipt, release, kitting, inventory control, and shipment of GMP materials, as well as supporting development teams with timely and accurate supply chain operations. The ideal candidate will have experience in GMP materials management and warehouse operations, strong organizational skills, and the ability to thrive in a fast-paced, collaborative biotech environment. Responsibilities Shipping & Receiving Perform receiving operations for both incoming materials and finished products. Schedule, prepare, and monitor shipments of final or intermediate products in compliance with GMP SOPs. Coordinate cold chain shipments from Adicet, ensuring proper packaging, documentation, and temperature control. Facilitate communications and address questions/concerns raised by partners such as clinical storage depots, distribution depots, and couriers Collaborate with domestic depot and international depots to provide oversight for international drug supply shipments including creation of commercial invoices and ensuring all documents needed by courier and importer of record are established Materials & Inventory Management Receive, inspect, release, and stock GMP materials, including cleanroom gowning, cleaning, and disinfection supplies. Prepare and kit materials for manufacturing in a timely and accurate manner. Maintain inventory management systems in compliance with standard warehouse practices (barcoding, FIFO, reorder triggers, manufacturing fill orders, etc.). Monitor inventory and generate reports on quantities, lot status, and expiration dates for stakeholders. Investigate and resolve inventory discrepancies promptly. Collaborate with QA on the disposition of GMP raw materials. Compliance & Continuous Improvement Ensure compliance with GMP, GDP, and applicable federal, state, and local regulations. Create, revise, and maintain SOPs related to materials management and supply chain processes. Drive continuous improvement in supply movement, warehouse optimization, and kitting processes. Complete day-to-day materials management tasks to ensure timely completion. Follow all safety procedures and support a culture of quality and compliance. Qualifications 24 years of relevant GMP materials management, supply chain, or warehouse/distribution experience in the pharmaceutical or biotech industry (experience level determines title). In-depth knowledge of pharmaceutical product shipment and warehouse operations in a GMP environment. Working knowledge of GMP, GDP, GCP, and relevant FDA guidelines. Technical skills in materials management with the ability to handle multiple priorities. Experience with international shipping logistics including generation of pro-forma and commercial invoices Understanding of import/export requirements including incoterms and importer of record roles Experience with cryogenic cold chain handling in a biopharmaceutical setting. Strong process orientation and attention to detail. Excellent verbal and written communication skills; able to collaborate across all levels of the organization. Highly self-motivated, adaptable to changing priorities, and comfortable in a fast-paced, small-company setting. Proficiency with MS Word, Excel, PowerPoint, and Outlook.