Key Responsibilities and Required Skills for Cell Therapy Associate

🎯 Role Definition

A Cell Therapy Associate is an entry- to mid-level manufacturing and laboratory specialist responsible for executing and supporting cGMP-compliant cell therapy operations. This role focuses on hands-on cell processing (autologous and allogeneic), aseptic technique, cryopreservation, sample handling, quality documentation, and cross-functional support for manufacturing, quality, and clinical teams. The ideal candidate combines strong laboratory techniques (cell culture, flow cytometry basics, viability assays) with rigorous documentation practices and a safety-first mindset to ensure timely, compliant delivery of investigational cell therapies.

Key SEO keywords: cell therapy associate, cell therapy manufacturing, CAR-T manufacturing, cGMP, aseptic technique, cell processing, cryopreservation, flow cytometry, clinical manufacturing, batch records.

📈 Career Progression

Typical Career Path

Entry Point From:

Research technician or lab technician in academic or commercial labs
Biomanufacturing / microbiology technician roles
Clinical research coordinator or cell processing technician

Advancement To:

Senior Cell Therapy Associate / Lead Manufacturing Technician
Process Development Associate / Scientist (Cell Therapy)
Quality Control (QC) Analyst or Quality Assurance (QA) Specialist
Manufacturing Supervisor / Production Lead

Lateral Moves:

Clinical Cell Processing Specialist
Analytical Development Technician (flow cytometry, PCR)
Supply Chain / Logistics for cellular shipments
Regulatory Affairs Associate (with QA experience)

Core Responsibilities

Primary Functions

Perform hands-on cell processing activities including thawing, washing, enrichment, activation, transduction, expansion, and formulation of autologous and allogeneic cell therapy products in accordance with written procedures and under cGMP/aseptic conditions.
Execute sterile aseptic technique in biosafety cabinets and cleanroom environments, including gowning, aseptic transfers, and critical manipulations to maintain product sterility and patient safety.
Prepare, assemble, and operate bioprocess equipment such as CO2 incubators, centrifuges, bioreactors/flasks, gas controllers, and cryopreservation systems to support cell culture and expansion workflows.
Conduct cell viability, cell count, and cell health assessments using hemocytometers, automated counters, trypan blue exclusion, and viability dyes, documenting results in batch records and laboratory notebooks.
Run basic analytical assays and in-process testing (e.g., flow cytometry for immunophenotyping, endotoxin testing, mycoplasma screening, sterility checks, PCR-based identity/identity assays) and coordinate with QC for release testing.
Maintain and accurately execute batch records, GMP manufacturing logs, and electronic or paper documentation ensuring legibility, traceability, and compliance with SOPs, cGMP, and regulatory expectations (FDA, EMA).
Execute cryopreservation and thaw protocols, including preparation of cryoprotectant solutions, controlled-rate freezing, and validated thaw procedures while maintaining chain-of-custody and lot traceability.
Perform lot release support activities such as sample collection, labeling, aliquoting, and shipping of clinical samples under regulated shipping standards (e.g., IATA/UN3373, dry ice handling).
Monitor and maintain environmental monitoring programs (settle plates, contact plates, viable air sampling), document excursions, and participate in contamination investigations and CAPA activities as required.
Support equipment qualification, preventive maintenance, calibration checks, and routine cleaning of GMP suites; escalate deviations and assist with root cause investigations for process or equipment issues.
Implement and adhere to safety protocols (Biosafety Level guidance, hazardous waste handling, sharps and chemical safety) and participate in safety training and drills.
Assist in process development activities by collecting and documenting process parameters, KPI metrics, and supporting scale-up or optimization experiments under the direction of senior scientists.
Coordinate with clinical operations to support patient-specific manufacturing schedules (apheresis receipt, chain-of-identity documentation, scheduled manufacturing, and release), maintaining strict timelines and traceability.
Participate in training, mentoring, and competency assessments for peers and new hires on critical manufacturing techniques, SOPs, and safety requirements to ensure team readiness and compliance.
Identify opportunities to improve manufacturing efficiency and quality by documenting non-conformances, proposing process improvements, and participating in continuous improvement initiatives.
Execute sample management duties including accessioning, labeling, storing, retrieving, and disposing of biological samples according to SOPs and sample retention policies.
Support reagent and inventory management—tracking lot numbers, expiration dates, cold chain receipts, and implementing first-expire-first-out (FEFO) practices in GMP storage areas.
Participate in internal and external audits and inspections by preparing documentation, answering routine process questions, and implementing corrective actions with QA oversight.
Lead or support documentation activities for protocol deviations, change controls, and CAPA documentation, ensuring timely and accurate completion and closure.
Maintain and update training records, competency matrices, and qualification documentation for manufacturing personnel to meet internal and regulatory requirements.
Support data entry, review, and reconciliation of manufacturing records in LIMS or MES systems, ensuring data integrity and alignment with paper records where applicable.
Execute and document routine QC sample preparation, aliquoting, and shipping to external analytical labs, coordinating timelines and tracking results for timely batch disposition.
Collaborate cross-functionally with Quality, Regulatory, Clinical, and Supply Chain teams to ensure alignment on manufacturing schedules, product release timelines, and regulatory obligations.
Maintain a high level of situational awareness for patient-specific therapies including chain-of-identity and chain-of-custody documentation and escalate any discrepancies immediately.

Secondary Functions

Assist in small-scale process development experiments to support feasibility studies and transfer activities, providing technical feedback and operational insights to development scientists.
Support preparation of materials and documentation required for regulatory submissions (IND/CTA support) and product comparability studies under senior leadership guidance.
Participate in cross-functional project teams to implement process improvements, technology transfers, and new assay validations; contribute operational perspective to project plans.
Provide input into SOP writing and revision, ensuring operational clarity and adherence to manufacturing realities; assist QA in the procedural rollout and training.
Support inventory and procurement workflows by documenting usage trends, notifying stakeholders of low stock, and participating in vendor communication for critical reagents/equipment.
Assist in vendor and supplier qualification activities by documenting performance, lot consistency, and escalating supplier quality issues to procurement and QA.
Provide on-call or extended-hours manufacturing support for patient-specific runs, including weekend or overnight duties when required by clinical timelines.
Help coordinate sample archiving and long-term storage logistics for clinical trial material in accordance with study protocols and regulatory requirements.
Participate in periodic mock recalls and emergency preparedness drills to ensure readiness for product retrieval or incident response.
Contribute to training materials, SOP quick-reference guides, and competency assessments to accelerate ramp-up of new manufacturing staff and minimize operational risk.

Required Skills & Competencies

Hard Skills (Technical)

Aseptic technique and sterile processing for cell therapies in GMP cleanroom environments.
Cellular assays: primary cell isolation, cell culture maintenance, activation, expansion, transduction/transfection basics, and characterization.
Cryopreservation and thaw procedures, controlled-rate freezing, and cold chain management.
Proficiency with laboratory equipment: biosafety cabinets, CO2 incubators, centrifuges, automated cell counters, cryogenic storage systems.
Flow cytometry sample preparation and basic analysis (immunophenotyping) or working knowledge to interface with analytical teams.
Good documentation practices (GDP) and direct experience completing GMP batch records, logbooks, and SOPs.
Understanding of cGMP, FDA and EMA regulatory expectations relevant to cell and gene therapy manufacturing.
Hands-on experience with in-process testing (viability, cell counts, endotoxin screens) and sample handling for QC/QA release processes.
Experience with LIMS, MES, or electronic batch record systems; strong computer literacy including Excel and data entry best practices.
Knowledge of environmental monitoring, contamination control, and root cause analysis methods (CAPA, deviation handling).
Familiarity with regulatory shipping requirements (IATA, UN3373) for clinical samples and human-derived materials.
Basic molecular biology techniques such as PCR/qPCR and nucleic acid handling (preferred).
Experience with inventory management, lot tracking, and FEFO principles in a regulated environment.

Soft Skills

Detail-oriented with strong documentation discipline to support regulatory compliance and audit readiness.
Excellent verbal and written communication skills for cross-functional collaboration and precise reporting.
Strong problem-solving and troubleshooting abilities under time-sensitive, patient-driven manufacturing constraints.
Ability to prioritize, multitask, and adapt to changing schedules in clinical manufacturing contexts.
Team player mentality with the ability to mentor peers and work collaboratively with scientists, QA, and clinical staff.
Accountability and ownership for quality outcomes with a patient-first mindset.
Comfort working in high-pressure environments that require strict adherence to protocols and timelines.
Continuous improvement mindset with the ability to suggest operational efficiencies and process optimizations.
Professionalism and ethical handling of sensitive patient and clinical data.

Education & Experience

Educational Background

Minimum Education:

Associate degree in Biological Sciences, Biotechnology, Medical Laboratory Technology, or related technical discipline. Equivalent hands-on experience in GMP manufacturing may be accepted.

Preferred Education:

Bachelor’s degree in Biology, Biochemistry, Immunology, Biomedical Engineering, or related life sciences field.

Relevant Fields of Study:

Cell Biology
Immunology
Biotechnology
Biomedical Engineering
Clinical Laboratory Science

Experience Requirements

Typical Experience Range:

1–4 years of laboratory or biomanufacturing experience; 0–2 years for entry-level associate roles with strong internship/academic lab experience.

Preferred:

2+ years directly supporting cell therapy manufacturing, autologous product processing, or clinical cell processing (e.g., CAR-T, TCR).
Prior experience in cGMP environment, aseptic manufacturing, and handling patient-derived cellular material.
Experience with electronic batch records, LIMS/MES, and quality systems (SOPs, deviations, CAPA).