The Materials Management Warehouse Senior Specialist provides oversight to warehouse operations and inventory logistics for cell and gene therapy manufacturing sites located in Boston and Cambridge.  This role provides leadership to managed service providers performing material receipt, inventory control, kitting, transport, and issuance of raw materials and components.  Additionally, this role oversees the receipt, transfer, storage, and pack-out of drug product.  The Materials Management Specialist serves as a subject matter expert (SME) for Materials Management, serving as department liaison for scheduling, escalations, and quality events. 

2nd Shift: Monday - Friday 2:30pm -11:00pm

Key Duties and Responsibilities:

• Subject Matter Expert (SME) for quality events related to Materials Management, including deviations, CAPAs, corrective actions (CAs), and impact assessments (IAs)

• Develop, revise, and implement SOPs and work instructions to reflect evolving regulatory and operational best practices

• Develop and deliver Materials Management on-the-job training (OJT).

• Manage warehouse assets, ensuring a constant state of compliance

• Review data from temperature monitoring devices and EMS as appropriate.  Investigate and resolve any temperature excursions

• Maintain an audit-ready facility by proactively identifying and resolving compliance gaps, conducting walkthroughs, and ensuring timely documentation closure and MES exception handling

• Provide oversight for drug product pack and label operations.  Serve as technical SME for serialization equipment and drug product pack-outs

• Provide Subject matter expert (SME) support for Oracle and inventory reconciliation.  Participate in the design of Oracle and material flows 

• Provide oversight of Materials Management safety programs to include powered industrial truck (PIT) and DOT compliance programs

• Serve as primary point of contact for stakeholder escalations and scheduling changes

• Provide scheduling and operational guidance to managed service providers

• Develop and maintain key performance indicators (KPI) to measure managed service provider performance.  Facilitate reviews with vendor management

• Administrate cycle counts and lead inventory reconciliation within warehouse and manufacturing areas.  Troubleshoot inventory and consumption discrepancies to ensure the timely closure of batches

Knowledge and Skills:

• Proficiency in cGMP compliance, warehouse operations, material control, and material logistics in a cleanroom environment

• Advanced knowledge of electronic systems including ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), and document management systems

• Demonstrated ability to lead investigations, manage vendor relations, and drive process improvements

Education and Experience:

• Bachelor’s degree in life sciences, supply chain, engineering or related field, or equivalent combination of education and experience

• 2+ years’ relevant experience in a supervisory, team lead, or senior operative role

• 3+ years’ experience supporting materials management operations within a cGMP-regulated pharmaceutical or biotech manufacturing environment