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Key Responsibilities and Required Skills for Cell Therapy Specialist

💰 $80,000 - $140,000

BiotechnologyCell TherapyClinical ManufacturingQuality

🎯 Role Definition

A Cell Therapy Specialist is a hands-on manufacturing and technical expert responsible for executing and improving clinical and commercial cell therapy processes under GMP. This role performs aseptic cell processing (CAR‑T, NK, TILs, gene‑modified cells), cryopreservation and thawing, in-process and release testing coordination, batch record documentation, and cross‑functional troubleshooting. The Specialist ensures chain of identity/custody, supports tech transfer and process development, drives quality investigations and CAPA activities, and collaborates with clinical, QA, and regulatory teams to deliver safe, compliant cellular products for clinical trials and commercial supply.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Manufacturing Technician — Cell Therapy / Aseptic Processing
  • Research Associate in Cell Biology / Immunology
  • Clinical Research Coordinator or Cell Processing Technician (apheresis center)

Advancement To:

  • Senior Cell Therapy Specialist / Lead Manufacturing Technician
  • Cell Therapy Manufacturing Supervisor / Team Lead
  • Process Development Scientist or Clinical Manufacturing Manager
  • Quality / Regulatory Lead for Cell Therapy

Lateral Moves:

  • Quality Assurance Specialist (GMP/QMS)
  • Regulatory Affairs Associate — Advanced Therapies
  • Flow Cytometry or Analytical Development Specialist

Core Responsibilities

Primary Functions

  • Execute GMP-compliant aseptic cell processing workflows including manual and semi-automated manufacturing steps for autologous and allogeneic cell therapies (CAR‑T, TCR, NK, TILs), ensuring product quality, safety, and identity from receipt of apheresis to final fill/finish and release.
  • Perform and document cell handling tasks such as cell isolation, activation, transduction/transfection, expansion, harvest, concentration, formulation, and cryopreservation using validated protocols and following batch records precisely.
  • Maintain strict chain of identity and chain of custody for patient and donor biological materials (apheresis products, leukopak, PBMCs), accurately tracking specimens and time/temperature metadata from collection through shipment and storage.
  • Operate and troubleshoot cell manufacturing equipment (bioreactors, centrifuges, isolators, closed system tubing sets, cell counters, cryogenic storage systems) and escalate technical issues with clear root-cause information.
  • Conduct cell viability and potency assays (cell counts, viability dyes, metabolic assays), prepare samples for flow cytometry and immunophenotyping, and interpret/record analytical results to inform in-process decisions and release criteria.
  • Prepare, review and complete GMP batch records, lot documentation, and production logs in electronic or paper systems; ensure all entries are accurate, dated, signed, and compliant with SOPs.
  • Perform controlled-rate freezing, standardized thawing procedures and cryostorage management; monitor and document temperatures and maintain replacement/backup protocols for freezer and liquid nitrogen systems.
  • Coordinate with clinical trial teams and apheresis centers to schedule patient material collection, confirm collection parameters, reconcile patient identifiers, and communicate collection and shipping instructions to external partners.
  • Execute product labeling, packaging, and release activities consistent with regulatory and clinical requirements; verify label accuracy, expiration, storage conditions and special handling instructions.
  • Support in-process and lot release testing coordination with QC labs (sterility testing, endotoxin, mycoplasma, residuals, identity assays), including packaging and shipment of test samples and timely communication of results to QA and clinical teams.
  • Participate in deviation investigations, non-conformance documentation, CAPA activities and corrective actions; draft technical narratives, contribute data, and implement process improvements to mitigate recurrence.
  • Follow environmental monitoring programs, maintain aseptic gowning discipline, perform cleanroom duties, and ensure facility hygiene to meet GMP environmental control and sterility assurance levels.
  • Train, mentor and qualify new manufacturing staff on aseptic technique, cell therapy processes, safety procedures, and site-specific SOPs; maintain training records and competency assessments.
  • Support technology transfer and scale-up activities by executing pilot runs, documenting process performance, and providing constructive feedback for process optimization and validation.
  • Maintain inventory control for critical reagents, disposables and cell therapy kits; verify lot numbers, expiration dates, storage conditions and perform quarantine/release of incoming materials per supplier qualification and GMP requirements.
  • Use laboratory information management systems (LIMS), electronic batch record systems (EBR), and other manufacturing software to record production data, generate reports, and support data integrity and audit readiness.
  • Support internal and external regulatory inspections and audits by preparing documentation, hosting inspectors in the manufacturing area, and responding to auditor questions with factual, GMP-aligned answers.
  • Participate in cross-functional meetings with Process Development, Quality, Regulatory, Clinical Operations and Supply Chain to align on study timelines, process changes, and risk mitigation strategies for product delivery.
  • Develop, revise and review SOPs, work instructions and protocol documents for manufacturing processes; help translate process changes into controlled documentation with version control and training plans.
  • Perform sample management and chain-of-custody tasks including aliquot preparation, sample labeling, frozen storage and transfer to QC or external labs, ensuring correct sample handling conditions and documentation.
  • Monitor, log and respond to deviations in controlled temperatures and environmental alarms (freezers, liquid nitrogen, storage containers); implement contingency procedures and report incidents per SOP.
  • Participate in product shipping operations for patient-specific and clinical supplies, ensuring compliance with IATA, DOT and international cold-chain regulations, and prepare shipping documents and temperature-controlled packaging.
  • Collect and analyze manufacturing metrics (yield, viability, contamination rate, turnaround time), generate trend reports, and recommend continuous improvement initiatives to improve throughput and reduce variability.
  • Promote a safety-first and compliance-focused culture in manufacturing through participation in safety reviews, risk assessments (FMEA), and continuous adherence to biosafety and occupational health standards.

Secondary Functions

  • Assist process development and analytical teams by providing manufacturing feedback, operational data, and suggestions for assay improvements or automation opportunities.
  • Support ad-hoc sample pulls and retrospective data collection to aid lot investigations, regulatory submissions, and stability programs.
  • Contribute to validation and qualification activities for equipment, utilities and computer systems by executing IQ/OQ/PQ tasks and documenting results.
  • Participate in cross-functional training initiatives, knowledge transfer workshops and clinical site support calls to improve handoffs and sample logistics.
  • Contribute to continuous improvement projects (lean, 5S, Kaizen) to streamline workflow, reduce waste and improve cell product yield and quality.
  • Help maintain quality systems by reviewing change controls, supplier quality metrics, and supporting vendor qualification for critical components like cryostorage containers, reagents and tubing sets.

Required Skills & Competencies

Hard Skills (Technical)

  • GMP-compliant aseptic technique and cleanroom practice for cell therapy manufacturing.
  • Hands-on cell culture and primary human cell handling (T cells, NK cells, PBMCs) including activation, expansion and transduction workflows.
  • Experience with autologous and allogeneic cell therapy processes including CAR‑T, TCR, NK cell and TIL manufacturing.
  • Proficiency with cryopreservation and controlled-rate freezing processes, storage in vapor/liquid phase nitrogen, and standardized thaw protocols.
  • Flow cytometry sample preparation and basic data interpretation for immunophenotyping and potency assessment.
  • Use of cell counting and viability instruments (e.g., Vi-CELL, NucleoCounter, Countess) and hemocytometer techniques.
  • Familiarity with sterility, endotoxin, mycoplasma testing workflows and coordinating sample submission to QC labs.
  • Electronic Batch Record (EBR) and LIMS experience; strong documentation skills and data integrity awareness.
  • Competency in equipment operation and routine maintenance for centrifuges, incubators, bioreactors, cell washers, and isolators.
  • Chain of custody/identity management for biologic materials, including reconciliation and documentation practices.
  • Knowledge of regulatory requirements (FDA, EMA, ICH) relevant to cell and gene therapies and clinical manufacturing.
  • Experience with deviation/CAPA systems, root cause analysis, and corrective action implementation.
  • Basic hands-on experience with sample shipping logistics under cold-chain requirements and IATA/DOT regulations.
  • Ability to read, write and revise SOPs, work instructions, and batch documentation with controlled change management.
  • Familiarity with quality management systems (QMS), audits, and inspection readiness for advanced therapy medicinal products (ATMPs).

Soft Skills

  • Strong attention to detail and meticulous documentation discipline required for GMP manufacturing.
  • Excellent cross-functional communication and collaboration skills; able to liaise with clinical, QA, QC, and external sites.
  • Problem-solving mindset with the ability to perform structured root cause analysis and drive corrective actions.
  • Time management and prioritization skills to manage multiple patient-specific batches and tight clinical timelines.
  • Adaptability and resilience in a fast-paced, high-stakes manufacturing environment where timelines are critical.
  • Coaching and mentoring capability to train new technicians and ensure competency retention on the team.
  • High ethical standards, integrity and commitment to patient safety and regulatory compliance.
  • Critical thinking and continuous improvement orientation to reduce variability and increase process robustness.
  • Strong observational skills for environmental monitoring, deviation detection and contamination control.
  • Professional written and verbal communication for reporting, documentation and interaction with regulatory bodies.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Biology, Cell Biology, Biotechnology, Immunology, Biomedical Engineering or related life sciences field.

Preferred Education:

  • Master's degree (MS) or PhD in Cell Biology, Immunology, Bioengineering or related discipline, or equivalent technical certification with extensive cell therapy manufacturing experience.

Relevant Fields of Study:

  • Cellular and Molecular Biology
  • Immunology
  • Biomedical Engineering
  • Biotechnology
  • Clinical Laboratory Science

Experience Requirements

Typical Experience Range: 2 — 7 years of hands-on experience in aseptic cell processing, cell therapy manufacturing, or relevant GMP biologics production.

Preferred: 3+ years of direct experience with autologous/allogeneic cell therapy (CAR‑T, TIL, NK), demonstrated GMP compliance history, experience with electronic batch records/LIMS, and prior exposure to clinical supply logistics and regulatory inspections.

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