Manufacturing Specialist

The Manufacturing Specialist supports and independently executes GMP manufacturing operations for TCR T, CAR T, and Allogeneic cell therapy investigational products. This role is based in Santa Monica, CA. with occasional support at the Tarzana, CA. sites as needed. The Manufacturing Specialist is responsible for successful execution of manufacturing processes, production readiness, material and equipment coordination, troubleshooting, documentation accuracy, and support of technology transfer. This role requires sound technical judgment, ownership of assigned activities, and the ability to work independently within established procedures and quality systems. You will serve as a technical contributor within the manufacturing team and supports the development of Associate Specialists through coaching, training, and process guidance. 

The primary purpose of this role is to execute manufacturing operations with a high level of quality, consistency, and independence. The Manufacturing Specialist supports clinical manufacturing, process implementation, technology transfer, GMP readiness, and continuous improvement. This role is expected to identify issues, resolve routine problems, escalate appropriately, and support right first-time execution across assigned manufacturing activities. 

Responsibilities

• Execute manufacturing operations according to batch records, SOPs, electronic work instructions, and cGMP requirements 

• Set up manufacturing areas and operate automated and manual cell therapy processing equipment 

• Ensure materials, equipment, documentation, and cleanroom areas are ready to support scheduled manufacturing activities 

• Support equipment procurement, installation, qualification, facility readiness, and technology transfer activities as needed 

• Follow and reinforce cleaning, gowning, aseptic technique, and contamination control expectations 

• Maintain appropriate inventories of materials, supplies, and consumables within manufacturing areas 

• Ensure required materials and equipment are identified, available, and ready in time for manufacturing execution 

• Troubleshoot routine manufacturing issues and escalate risks or deviations as appropriate 

• Support Process Development, MSAT, Quality, Supply Chain, and F&E to align manufacturing activities with process and business needs 

• Support drafting, revision, review, and implementation of SOPs, batch records, and production documentation 

• Participate in deviation investigations, CAPA implementation, change controls, and quality record support as needed 

• Provide verbal and written updates to Manufacturing leadership 

• Support shift handover communication and ensure critical production information is clearly transferred between teams 

• Assist with training and mentoring Associate Specialists 

• Identify opportunities to improve safety, quality, schedule adherence, and production flow 

• Perform other responsibilities and project-based assignments as needed to support manufacturing operations 

• 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, or materials 

• Maintaining production readiness across materials, equipment, documentation, 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 and coaching 

Required Qualifications 

• At least 2+ years with BS/BA in relevant science or engineering discipline with 1-3 years of experience in cGMP or cell therapy manufacturing

• Understanding of cGMP processes and regulated manufacturing requirements 

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

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

• 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 

• 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, or automated cell processing equipment 

• Experience supporting deviation investigations, CAPAs, change controls, SOP revisions, or batch record improvements 

• Experience with paper and electronic batch records, manufacturing execution systems, inventory systems, or quality management systems 

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

#CellTherapy

The annual base pay for this position ranges from $68K to $102K. 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.