cGMP Materials & Inventory Control Specialist

Precigen; Germantown (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

Precigen in Germantown, MD is seeking a materials management professional responsible for cGMP inventory control, material movements, and compliant records to support cell and gene therapy manufacturing.

The role includes receiving, inspecting, dispositioning, replenishing and shipping of controlled materials, performing cycle counts, and maintaining a precise inventory system across GMP operations. Strong computer skills and attention to detail are essential.

Qualifications

• Associate or bachelor’s degree in life science or supply chain management, or equivalent combination of education and experience.
• 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

Attention to detail

Interpersonal skills

Team collaboration

Analytical skills

Microsoft Office proficiency

Education

Associate or bachelor’s degree in life science or supply chain management

Equivalent combination of education and experience

Tools

Inventory Management Systems/ERP

OE/5S

Job description

Precigen in Germantown, MD is seeking a materials management professional responsible for cGMP inventory control, material movements, and compliant records to support cell and gene therapy manufacturing.

The role includes receiving, inspecting, dispositioning, replenishing and shipping of controlled materials, performing cycle counts, and maintaining a precise inventory system across GMP operations. Strong computer skills and attention to detail are essential.