Job Description

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Senior Material Handler will oversee Materials Management (MM) operations at our Princeton facility within a GMP-compliant Contract Development and Manufacturing Organization (CDMO). This is a highly autonomous role suited for a professional with extensive experience managing materials in GxP-regulated environments. The ideal candidate will possess deep knowledge of Good Documentation Practices (GDP) and be comfortable making informed decisions in a fast-paced, compliance-driven setting. This position will work closely with cross-functional teams and be expected to operate with minimal supervision while maintaining audit readiness and operational excellence.

Key Responsibilities

• Serve as the primary point of contact and subject matter expert for all materials handling, inventory control, and GMP warehouse operations at the Princeton site.
• Independently receive, inspect, and verify incoming materials, reagents, consumables, and equipment in compliance with GMP standards and company SOPs.
• Forecast material usage to accurately and proactively coordinate with procurement for delivery to meet planned production schedules.
• Execute and document material transactions in ERP or inventory systems, ensuring real-time accuracy and traceability.
• Oversee internal lot assignment, labeling, quarantine, and release workflows, including coordination with Quality Assurance.
• Maintain and monitor storage conditions (ambient, refrigerated, frozen) to ensure compliance with material-specific requirements.
• Accurately stage, issue, and track materials for use in production, quality control, and development activities per BOMs and material request forms.
• Lead cycle counts, discrepancy resolution, and inventory reconciliation initiatives to support audit readiness and operational efficiency.
• Ensure strict GDP-compliant documentation across all materials handling processes and logs.
• Handle hazardous and controlled substances in accordance with internal protocols and applicable safety/regulatory standards.
• Collaborate with QA, Procurement, Manufacturing, and R&D to resolve material issues, ensure readiness of critical items, and maintain status visibility across departments.
• Actively support and initiate deviation reports, nonconformance investigations, and CAPA actions related to material workflows.
• Maintain warehouse organization, drive 5S initiatives, and ensure facility inspection readiness at all times.
• Provide occasional support to the Princeton site, up to 20% of the time, based on business needs.
• Other duties as assigned

Must Haves

• 5+ years of hands-on experience in a GMP/CDMO, pharmaceutical, or biotech environment with increasing levels of responsibility in materials management or warehouse operations.
• Demonstrated ability to operate independently and lead site-level MM functions with minimal oversight.
• Experience with investigating non-conforming materials, out-of-specification test results, and process deviations within a cGMP environment.
• Strong working knowledge of GxP, GDP, and material control requirements under 21 CFR Part 211 or equivalent.
• Experience with material receiving, internal lot tracking, issuance, reconciliation, and compliance documentation.
• Proficiency in ERP or warehouse management systems (SAP, Oracle, NetSuite, etc.).
• High attention to detail and proven ability to execute and troubleshoot material workflows in a regulated environment.
• Physical ability to lift up to 50 lbs and work within temperature-controlled environments.
• Ability to pass a DOT physical examination to drive a company vehicle.
• Excellent communication and cross-functional collaboration skills.

Good to Haves

• Experience in implementing and configuring electronic systems including ERP, MES, LIMS, and QMS
• Proficiency with cold chain logistics, including validated cold storage equipment and shipping practices.
• Familiarity with barcode/RFID-based inventory tracking or warehouse scanning systems.
• Prior experience working in or closely with Quality Assurance or Regulatory Affairs teams, especially regarding material release workflows.
• Understanding of raw material risk classification, vendor qualification processes, and CoA/CofC review procedures.
• Forklift certification and experience operating pallet jacks or other warehouse equipment.
• Basic understanding of temperature/humidity monitoring systems, data loggers, and alert systems.
• Experience leading or supporting warehouse or process audits (internal or external).
• Familiarity with SDS interpretation and hazardous material labeling/handling under OSHA, DOT, or IATA.

Required Degree

• Bachelor’s degree in logistics, supply chain, or a science-based discipline (e.g., biology, chemistry, biotechnology) required. Associate’s degree with exceptional experience may be considered.

Physical Requirements

• Ability to perform essential job functions in a warehousing environment, including prolonged periods of sitting or standing.
• Must maintain regular, punctual attendance in accordance with company policies and legal requirements.
• Ability to use a computer and other standard office equipment for extended periods.
• Ability to lift up to 50 lbs.
• Ability to work within temperature-controlled environments.

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