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 . 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 $68484.00 - $ positions offer eligibility for various incentivesan 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.