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 equipment procurement, installation, qualification, facility readiness, and technology transfer activities as needed.
Follow and reinforce cleaning, gowning, aseptic technique, cleanroom behavior, and contamination control expectations.
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.
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 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
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.
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.
Preferred Qualifications
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.
Key Relationships
Internal: Manufacturing Management, Lead Specialists, Associate Specialists, Quality, MSAT, Process Development, Supply Chain, EHS, and Facilities and Engineering.
Working Conditions
Must be able to perform manufacturing activities that require repetitive movement, reaching, bending, and careful handling of materials or equipment.
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.
Date Posted
18-Sep-2026
Closing Date
17-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.