Manufacturing Specialist, Cell Therapy

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. 

• Perform or support Final Drug Product (FDP) visual inspection activities, when assigned, in accordance with site procedures, including meeting and maintaining annual visual acuity requirements. 

• You Are Accountable For 

• Independent execution of assigned manufacturing operations in compliance with cGMP. 

• Right first time performance across assigned process steps. 

• Accurate and complete documentation in real time. 

• Timely escalation of issues that may impact safety, quality, schedule, staffing, equipment, materials, compliance, or patient supply. 

• Maintaining production readiness across people, materials, equipment, documentation, electronic systems, and cleanroom areas. 

• Supporting schedule adherence and cycle time expectations. 

• Contributing to deviation investigations with clear facts, process understanding, and timely input. 

• Supporting Associate Specialist development through training, coaching, and technical guidance. 

• Serving as a technical resource for assigned processes and equipment within the manufacturing area. 

Required Qualifications 

• High School Diploma with at least 2 years of relevant experience in science, engineering, life sciences, or a related discipline. 

• Understanding of cGMP processes, regulated manufacturing requirements, SOPs, batch records, and quality systems. 

• Knowledge of aseptic technique, cleanroom behavior, contamination control, and GMP documentation practices. 

• Experience supporting GMP clinical manufacturing, technology transfer, process implementation, or regulated manufacturing execution. 

• Ability to develop solutions to routine and moderately complex problems using established procedures, precedent, and sound judgment. 

• Ability to plan and organize assigned work with limited supervision. 

• Strong written and verbal communication skills. 

• Ability to work effectively in a fast-paced and changing manufacturing environment. 

Preferred Qualifications 

• Cell therapy manufacturing experience. 

• Experience with primary human cell culture, single-use technologies, automated cell processing equipment, or process analytical technologies. 

• Experience supporting deviation investigations, CAPAs, change controls, SOP revisions, batch record improvements, or inspection readiness activities. 

• Experience with paper or electronic batch records, MES, inventory systems, quality management systems, or scheduling systems. 

• Familiarity with CMC regulatory expectations for biologics or cell therapy products. 

• Proficiency in Microsoft Word, Excel, and data analysis. 

Key Relationships 

• Internal: Manufacturing Management, Lead Specialists, Associate Specialists, Quality, MSAT, Process Development, Supply Chain, EHS, and Facilities and Engineering. 

• External: Vendors or external partners as assigned. 

Working Conditions 

• Must be able to work in a cleanroom environment that requires gowning. 

• Must be able to stand for extended periods of time. 

• Must be able to perform manufacturing activities that require repetitive movement, reaching, bending, and careful handling of materials or equipment. 

• Required to carry and lift up to 30 pounds several times a day while handling production equipment or materials. 

• Required to push or pull up to 50 pounds several times a day while handling production equipment or materials. 

• May work in classified cleanroom environments and with sophisticated automated cell processing, cell expansion, and filling equipment. 

• May work in areas with strong magnets or specialized manufacturing equipment. 

• May work in areas where human blood products or other biological materials are handled. 

• May work in areas with exposure to vapor phase liquid nitrogen or cryogenic materials. 

• Must be able to work assigned shifts, weekends, holidays, and overtime as required by the manufacturing schedule. 

• Must follow all safety, contamination control, gowning, documentation, and cGMP requirements. 

General Statement 

This job description describes the general nature and level of work expected for this role. It does not list every responsibility, duty, or skill required. Employees in this role may be asked to perform other job-related duties as needed to support Manufacturing operations, patient supply, site readiness, commercial readiness, and business priorities.

The annual base pay (or hourly rate of compensation) for this position ranges from $68,484.00 - $102,726.00. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.