Made Scientific
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.
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.