GMP Warehouse Lead - 24/7 Ops & SAP Expert

Miltenyi-Biote; Gaithersburg (MD); On-site; USD 76,000 - 89,000; Full time

Job summary

Miltenyi Biotec North America seeks a skilled Warehouse Supervisor to lead a team of eight to ten MM Associates in a GMP environment. You will oversee receiving, storage, picking, packing, shipping, and inventory management across ambient and cold storage areas.

You will coach staff, maintain SOPs, resolve issues, and drive continuous improvement through GMP knowledge and lean methods. Experience in SAP MM and regulatory readiness is essential.

Qualifications

• 5+ years in warehousing or related operations.
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Responsibilities

• Supervise, train, and coach materials management associates to develop a high performing and diverse team capable of supporting 24/7 commercial LV manufacturing and CGT manufacturing.
• Provide daily supervision of all general warehouse functions to include receiving, put away, stock replenishment, picking, packing, shipping, and basic inventory transactions in a GMP environment.
• Lead the material management team to operate in a safe and compliant manner at all times.
• Assign daily tasks and adjusts resources throughout the day based on workload and operational priorities.
• Troubleshoot inventory, equipment, and system issues to identify resolution, as needed, escalates issues effectively to supporting functions.
• Lead team huddle, approve vacations, and providefirst level support to staff on escalated issues.
• Author and edit Standard Operating Procedures (SOPs) as needed.
• Lead corrective actions associated with deviations and audit findings.
• Provide daily status reports and metrics as directed to manager with recommendations on ways to improve performance if needed.
• Act as a subject matter expert on all processes, equipment, and procedures.
• Ensure appropriate levels of packaging supplies are maintained, and work areas are organized.
• Lead continuous improvement for warehouse operations through Yellow Belt, Green Belt, and 5S initiatives.
• Support and leadoperational tours associated with client, internal, and regulatory audits.
• Manage commercial drug substance freeze-down, storage, cell bank storage, distribution and shipment to clients.
• Helpclient audits for the Materials Management organization, serving as the subject matter expert.
• SupportFDA regulatory inspections and ensuring GMP compliance with no critical observations within the department.
• Other duties as assigned.

Skills

Leadership

SAP MM ERP

Microsoft Office

GMP/GxP

Regulatory knowledge

Education

High School Diploma or Equivalent

Tools

SAP MM

TrackWise

QUMAS

QLIMS

Veeva

MasterControls

ENNOV

Job description

Miltenyi Biotec North America seeks a skilled Warehouse Supervisor to lead a team of eight to ten MM Associates in a GMP environment. You will oversee receiving, storage, picking, packing, shipping, and inventory management across ambient and cold storage areas.

You will coach staff, maintain SOPs, resolve issues, and drive continuous improvement through GMP knowledge and lean methods. Experience in SAP MM and regulatory readiness is essential.