Manufacturing Specialist, Cell Therapy

Responsibilities

• ● The Manufacturing Specialist, Cell Therapy independently executes GMP manufacturing operations for TCR T, CAR T, and allogeneic cell therapy investigational products. The role is responsible for successful execution of manufacturing processes, production readiness, material and equipment coordination, troubleshooting, documentation accuracy, Final Drug Product support as assigned, and support of technology transfer and continuous improvement activities.
• ● Purpose and Scope The primary purpose of this role is to execute manufacturing operations with a high level of quality, consistency, and independence. The Manufacturing Specialist serves as a technical contributor within the manufacturing team, supports clinical manufacturing, process implementation, technology transfer, GMP readiness, and continuous improvement, and helps develop Associate Specialists through coaching, training, and process guidance.
• ● Typical Accountabilities
• ● Execute manufacturing operations according to batch records, SOPs, electronic work instructions, and cGMP requirements with a focus on right first time execution.
• ● Set up manufacturing areas and operate automated and manual cell therapy processing, cell expansion, filling, and support equipment.
• ● Ensure materials, equipment, documentation, cleanroom areas, and electronic systems are ready to support scheduled manufacturing activities.
• ● Author, review, or support updates to manufacturing batch records, work instructions, SOPs, logbooks, bill of materials, and production documentation as assigned.
• ● Support batch record reconciliation, documentation review, and timely closure of manufacturing records.
• ● Support equipment procurement, installation, qualification, facility readiness, and technology transfer activities as needed.
• ● Participate in technology transfer activities and support process development or MSAT studies and experiments when assigned.
• ● Follow and reinforce cleaning, gowning, aseptic technique, cleanroom behavior, and contamination control expectations.
• ● Maintain appropriate inventories of materials, supplies, and consumables within manufacturing areas.
• ● Troubleshoot routine and moderately complex manufacturing, documentation, material, or equipment issues and escalate risks or deviations appropriately.
• ● Support Process Development, MSAT, Quality, Supply Chain, EHS, and Facilities and Engineering to align manufacturing activities with process and business needs.
• ● Participate in deviation, non-conformance, OOS, CAPA, and change control support by providing clear facts, process understanding, and timely input.
• ● Provide verbal and written updates to Manufacturing leadership, including production status, risks, and escalation needs.
• ● Support shift handover communication and ensure critical production information is clearly transferred between teams.
• ● Train and mentor Associate Specialists on GMP principles, aseptic technique, equipment operation, process execution, documentation, and cleanroom behavior.
• ● Identify opportunities to improve safety, quality, schedule adherence, production flow, cost awareness, and team effectiveness.
• ● Perform other responsibilities and project-based assignments as needed to support manufacturing operations.