Key Responsibilities and Required Skills for Cell Therapy Manufacturing Associate

🎯 Role Definition

The Cell Therapy Manufacturing Associate performs end-to-end GMP manufacturing tasks for cellular medicines, including aseptic processing, cell culture, equipment operation, sample handling, and controlled documentation to support the timely and compliant release of clinical and commercial cell therapy products (e.g., CAR-T, TIL, NK, stem cell derived therapies). This role requires strict adherence to cGMP, Chain of Identity/Chain of Custody procedures, environmental and sterility controls, and close collaboration with quality, clinical, and supply chain teams to ensure patient-centric, high-integrity manufacturing.

📈 Career Progression

Typical Career Path

Entry Point From:

Manufacturing Technician (Biologics / Aseptic)
Cell Processing Technician or Cell Culture Technician
Research Associate in cell biology or immunology

Advancement To:

Senior Cell Therapy Manufacturing Associate
Process Development Scientist (Cell Therapy)
Manufacturing Team Lead / Supervisor
Quality Assurance Associate (GMP)

Lateral Moves:

Quality Control / Analytical Technician (flow cytometry, sterility)
Clinical/Commercial CMC Operations Coordinator
Supply Chain / Logistics Specialist for patient material

Core Responsibilities

Primary Functions

Execute cGMP-compliant aseptic processing of autologous and allogeneic starting material, including cell isolation, activation, transduction (or transfection support), expansion, harvesting and formulation using closed and semi-closed systems while maintaining Chain of Identity and Chain of Custody for patient products.
Operate, program, troubleshoot and perform routine preventive maintenance and cleaning of automated cell processing and bioprocessing platforms (e.g., CliniMACS Prodigy, Sepax, Xuri, rocking bioreactors, automated cell washers) following SOPs and equipment-specific work instructions.
Perform precise cell counting, viability assessment, and QC sample collection (e.g., trypan blue counts, automated counters, viability dyes) and prepare and label in-process and release samples for downstream analytical testing and lot release.
Conduct sterile fill and finish, aseptic transfers, formulation and cryopreservation (controlled-rate freezing) of cellular products and manage controlled thawing procedures, ensuring integrity of product and adherence to validated cryoprotectant usage.
Prepare and sterilize reusable components, single-use assemblies, and consumables; stage, inspect and gown sterile consumables to ensure readiness for manufacturing campaigns and maintain inventory levels to prevent production delays.
Accurately execute batch records, electronic manufacturing records (EMR), logbooks, and LIMS entries in real-time; document deviations, non-conformances, and near-misses with comprehensive detail to support root cause analysis and CAPA.
Follow and support environmental monitoring programs including airborne particle counts, surface sampling, viable and non-viable monitoring data collection, gowning audits and cleanroom behavior monitoring to ensure compliance with cleanroom classification and release criteria.
Complete product transfers, sample shipments, and cold-chain logistics coordination for patient product pick-up and delivery; ensure proper labeling, temperature monitoring, and documentation for patient-specific or clinical trial material.
Implement aseptic technique and sterile gowning practices during all manipulations; lead by example to maintain a contamination-free environment and rigorous personal behavior inside controlled areas.
Prepare and reconstitute media, buffers, and reagent solutions under aseptic and controlled conditions according to validated recipes, including QC checks and verification of sterility and pH/osmolality where required.
Support in-process and release testing activities such as cell phenotype staining, sample prep for flow cytometry, cell potency assay sample collection, endotoxin and mycoplasma sample handling with appropriate chain-of-custody and cold-chain requirements.
Participate in technology transfers and scale-up activities by executing and documenting pilot runs, comparing process parameters, capturing process variability, and providing frontline feedback to process development teams.
Identify, record and escalate process deviations and product quality trends; participate in initial investigations, containment actions and corrective measures in partnership with Quality Assurance to support timely CAPA closure.
Train, mentor and qualify new manufacturing associates on SOPs, batch record execution, aseptic technique, and site-specific procedures; maintain training matrices and complete qualifications required for authorized tasks.
Execute product hold, quarantine and disposition procedures under QA direction; prepare and coordinate disposition documentation and sample release for clinical or commercial use.
Participate in internal and external audits and inspections by preparing required documentation, demonstrating processes, and implementing corrective actions as needed to address audit findings.
Perform equipment qualification support tasks including PQ runs, data collection, calibration verification and instrument qualification documentation to ensure equipment is fit-for-purpose.
Conduct routine cleaning, sanitation, and gowning/take-off procedures of controlled areas and equipment and document cleaning logs, ensuring compliance with validated cleaning procedures and contamination control plans.
Assist in the development, review and continuous improvement of SOPs, work instructions, batch records and manufacturing templates to enhance clarity, reduce errors and increase operational efficiency.
Monitor and manage product and reagent inventory cycles; place orders, receive and verify shipments, check certificates of analysis (CoA) and quarantine materials pending QA release to maintain uninterrupted manufacturing schedules.
Work flexible schedules, including occasional nights and weekends, to accommodate patient treatment schedules and clinical timelines, ensuring timely manufacture and delivery of patient-specific therapies.

Secondary Functions

Support process improvement initiatives using lean manufacturing principles to reduce cycle time, minimize waste, and improve overall reliability of cell therapy manufacturing operations.
Assist Quality and Process Development teams in small-scale experiments, stability runs, and process characterization studies to capture manufacturing feasibility data.
Participate in cross-functional meetings with clinical, logistics, and QA teams to align production schedules with patient treatment timelines and clinical trial requirements.
Provide ad-hoc data entry and reporting for manufacturing metrics, yield tracking, deviation trends and environmental monitoring trends to support continuous improvement and regulatory readiness.
Help maintain training records, qualification status and competency assessments for the manufacturing team; propose training updates when process changes are implemented.
Contribute to periodic risk assessments (FMEA) for process steps under your control and provide frontline observations to mitigate contamination or chain-of-identity risks.
Assist with vendor and supplier qualification activities by verifying component specifications during incoming inspection and supporting documentation review for critical consumables.
Provide on-floor support during mock recalls, emergency simulations and product hold exercises to ensure preparedness for product quality events.

Required Skills & Competencies

Hard Skills (Technical)

Strong knowledge and proven hands-on experience with cGMP manufacturing practices for cell therapies, including Chain of Identity and Chain of Custody procedures.
Expert aseptic technique and sterile gowning competency for work inside ISO 5/7/8 cleanroom environments.
Familiarity with closed-system automated cell processing platforms (e.g., CliniMACS, Sepax), single-use assemblies, and bioreactor operations.
Practical experience with cryopreservation and thawing of cellular products, controlled-rate freezers, and cold-chain logistics for patient material.
Proficiency with cell biology techniques: cell counting, viability assays, basic cell culture, cell washing, and concentration adjustments.
Experience preparing, executing and completing batch records and electronic manufacturing records (EMR) with attention to accuracy and timelines.
Competence in performing and documenting environmental monitoring activities, including viable and non-viable monitoring and gowning/environmental audits.
Working knowledge of sample handling for QC assays (flow cytometry prep, endotoxin, sterility, mycoplasma) and understanding of sample chain-of-custody.
Ability to operate and perform basic troubleshooting and preventive maintenance on laboratory and GMP equipment; familiarity with instrument qualification processes (IQ/OQ/PQ).
Experience using LIMS, electronic batch record systems, and standard lab software (e.g., Excel, electronic deviation systems).

Soft Skills

Strong attention to detail and high personal accountability in written documentation and execution of GMP procedures.
Excellent manual dexterity and visual acuity required for delicate aseptic manipulations.
Good problem-solving skills with ability to identify issues, escalate appropriately and participate in root cause analyses.
Clear communicator able to collaborate across quality, process development, clinical and supply chain teams.
Strong organizational skills, ability to prioritize tasks in a fast-paced, patient-focused manufacturing environment.
Adaptable and flexible with a patient-first mindset and willingness to work non-standard hours to meet clinical deadlines.
Continuous improvement mindset with curiosity to suggest process efficiencies and reduce variability.
Team-oriented with coaching and mentorship capabilities to support junior staff development.

Education & Experience

Educational Background

Minimum Education:

Associate degree in Biological Sciences, Biotechnology, Cell Biology, or related laboratory/technical discipline; or equivalent hands-on GMP manufacturing experience.

Preferred Education:

Bachelor of Science (BS) in Biology, Biotechnology, Biomedical Engineering, Immunology or related field; Master's degree preferred for advanced process development roles.

Relevant Fields of Study:

Cell Biology, Molecular Biology, Immunology
Biotechnology, Bioprocess Engineering
Biomedical Science, Clinical Laboratory Science

Experience Requirements

Typical Experience Range: 1–5 years of hands-on experience in aseptic manufacturing, cell culture, or biologics production; 1–3 years preferred for entry-level roles into cell therapy.

Preferred:

2+ years of direct experience working in GMP or regulated cell therapy or biologics manufacturing environments, with documented competence in aseptic processing, batch record completion, and environmental monitoring.
Experience supporting autologous or allogeneic cell therapy programs, CAR-T, TCR, or gene-modified cell product manufacturing is highly desirable.
Demonstrated experience with LIMS/electronic batch record systems and participation in FDA/EMA inspection readiness preferred.