cGMP Materials Management Specialist II

Precigen; Germantown, Northern (MD, KY); Hybrid; USD 70,000 - 80,000; Full time

Job summary

Precigen in Germantown, MD is seeking a Full-time Materials Management professional to support cGMP manufacturing of cell and gene therapy products. You will perform hands-on operations including receiving, inspecting, and shipping of controlled materials, ensuring documentation accuracy and regulatory readiness.

The role requires an associate or bachelor’s in life science or supply chain, at least 4 years in a regulated environment, and familiarity with ERP systems and OE/5S.

Qualifications

• Associate or bachelor’s degree in life science or supply chain management.
• Minimum of 4 years’ experience in a regulated materials management environment.
• Knowledge of principles and practices of current Good Manufacturing Practices (cGMPs).
• Working knowledge of GMP/GDP, material traceability, data integrity, and warehouse controls.
• Experience in biotechnology, biopharmaceutical, pharmaceutical, or another regulated industry.
• Strong computer skills with Microsoft Office and the ability to quickly learn new applications.
• Experience with Inventory Management Systems/ERP and OE/5S is a plus.

Responsibilities

• Perform materials management activities with cGMP compliance and support regulatory audit readiness.
• Perform hands-on materials management operations including receiving, inspecting, dispositioning, replenishing and shipping of controlled materials and supplies for cGMP manufacturing of cell and gene therapy products.
• Receive and inspect incoming materials to ensure shipment integrity, accurate quantities, proper documentation and labeling, and compliance with purchase-order accuracy.
• Investigate inventory discrepancies, temperature excursions, damaged shipments, and material-related deviations.
• Support change controls, CAPAs, deviations, supplier qualification, and risk assessments.
• Work with Manufacturing, Quality Control, and Quality Assurance teams and inventory systems to ensure adequate materials are available and released in time to support GMP production.
• Coordinate and ship products, samples, and ensure temperature sensitive material reaches their destinations on time and in full.
• Create and/or update raw material/supplies specification as well as develop or modify SOPs for material management processes, as necessary.
• Organize storage rooms, perform cycle counts, data entry to maintain a cGMP inventory system thus ensuring all our departments have adequate access to the materials they need.
• Perform disposition of all expired materials and maintain applicable documentation.
• Monitor temperature conditions of refrigerators, freezers, and room temperature storage of cGMP materials.
• Coordinate sampling, testing, release, and disposition with Quality Assurance and Quality Control.
• Other duties as assigned.

Skills

cGMP compliance

GMP/GDP knowledge

data integrity

warehouse controls

Microsoft Office

team collaboration

Education

Associate or Bachelor's degree in Life Science or Supply Chain

Tools

Inventory Management Systems/ERP

OE/5S

Job description

Precigen in Germantown, MD is seeking a Full-time Materials Management professional to support cGMP manufacturing of cell and gene therapy products. You will perform hands-on operations including receiving, inspecting, and shipping of controlled materials, ensuring documentation accuracy and regulatory readiness.

The role requires an associate or bachelor’s in life science or supply chain, at least 4 years in a regulated environment, and familiarity with ERP systems and OE/5S.