Role Summary
Material Management Manager-based position at the Germantown, MD location responsible for all aspects of materials management and flow, with control and accuracy over inventory. The role requires a proactive professional who thrives in a dynamic team environment and can implement improvements.
Responsibilities
- Lead the materials management program and management of supporting staff and their development.
- Perform hands-on materials management operations including ordering, receiving, inspecting, dispositioning, and stocking of raw material and supplies for cGMP manufacturing of cell and gene therapy products.
- Work with Facilities, Manufacturing, Quality Control, and Quality Assurance teams to support local GMP and non-GMP activities.
- Coordinate and ship products, samples, and ensure temperature sensitive material reach 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.
- Implement and maintain strict GMP procedures and lead any efforts required to address and close any material deviations or non-conformance.
- Collaborate with Manufacturing, Quality Control, and Quality Assurance in supporting internal and external cGMP compliant operations, regulatory audit preparedness.
- Perform disposition of all expired materials and maintains applicable documentation.
- Support Facilities with the management of refrigerators, freezers, and room temperature storage of cGMP materials.
- Work closely with the Planning/Buying team and suppliers to ensure efficient material throughput supporting local activities.
- Drive continuous improvement of supplies, movement and processes to reduce waste and improve service levels.
Qualifications
- Bachelor's degree in life science or supply chain management.
- Minimum of 6 yearsβΓΓ΄ experience in a regulated materials management environment.
- Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs).
- Experience in organizing and management of GMP warehouse inventory, specifically in the biotech/pharma/consumer goods industries.
- Experience with regulatory audits of cGMP manufacturing sites.
- Technical working knowledge and/or experience with materials across CRT, 2-8C, -20C.
- Experience with validated ERP system for cGMP environment required. Experience with ERP implementation is preferred.
- Excellent computer skills with Microsoft Office and the ability to quickly learn new applications.
Education
- Bachelor's degree in life science or supply chain management.
Additional Requirements
- Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies.
- May need to work with hazardous materials.
- Able to stand up to 4 hours at a time.