GMP Materials Coordinator II – Cell & Gene Therapy

Precigen, Inc; Germantown (MD); On-site; USD 70,000 - 80,000; Full time

Job summary

Precigen, Inc. in Germantown, MD seeks a full-time Materials Management professional to support cGMP manufacturing of cell and gene therapy products.

Responsibilities include receiving, inspecting, dispositioning, replenishing, and shipping materials while ensuring documentation and labeling accuracy. The role requires 4+ years in regulated materials management, knowledge of cGMP/GMP, ERP experience, and strong teamwork with Manufacturing, QC, and QA to keep GMP production materials released on

Qualifications

• 4 years of experience in a regulated materials management environment.
• Knowledge of cGMP, GMP/GDP, and data integrity.
• Proficient with inventory management systems and ERP.
• Strong attention to detail and teamwork.
• Proficient with Microsoft Office.

Responsibilities

• Perform materials management with cGMP compliance and audit readiness.
• Handle receiving, inspecting, disposal, replenishment, and shipping of materials.
• Ensure shipment integrity, accurate quantities, documentation, and labeling.
• Investigate inventory discrepancies, temperature excursions, and deviations.
• Support change controls, CAPAs, deviations, and supplier qualification.
• Coordinate with Manufacturing, QC, QA to release materials in time.
• Coordinate sampling, testing, release, and disposition with QA/QC.
• Maintain cGMP inventory systems and cycle counts.
• Disposal of expired materials and maintain required documentation.
• Adhere to safety and ethical standards; occasional after-hours work.

Skills

cGMP compliance

Inventory management

Data entry

ERP systems

Microsoft Office

GMP/GDP knowledge

Attention to detail

Education

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

Tools

OE/5S

Job description

Precigen, Inc. in Germantown, MD seeks a full-time Materials Management professional to support cGMP manufacturing of cell and gene therapy products.

Responsibilities include receiving, inspecting, dispositioning, replenishing, and shipping materials while ensuring documentation and labeling accuracy. The role requires 4+ years in regulated materials management, knowledge of cGMP/GMP, ERP experience, and strong teamwork with Manufacturing, QC, and QA to keep GMP production materials released on