CELL THERAPY SPECIALIST JOB DESCRIPTION

A Cell Therapy Specialist executes aseptic manufacturing of clinical and commercial cell products under cGMP. The role owns the bench: from cell selection and cryopreservation through cleanroom maintenance, deviation documentation, and SOP authorship, it is the technical core of a regulated manufacturing operation. FACT, CAP, and FDA compliance requirements make precision non-negotiable. Grade A and Grade B cleanroom environments demand both scientific rigor and procedural discipline in equal measure.

As the Cell Therapy Specialist, you ensure clinical and commercial cell therapy products meet regulatory and quality standards through hands-on GMP manufacturing, analytical testing, and process documentation. You work within a small manufacturing team alongside Process Development, Quality Assurance, and Material Management functions, contributing directly to patient-ready product release.

Career Impact: Hands-on experience manufacturing CAR-T and other advanced cell therapy products places you among a small, highly credentialed segment of the biotech workforce where ASCP certification and cGMP fluency are genuine market differentiators.

Business Impact: Every batch record completed accurately and every deviation caught early determines whether a clinical or commercial lot reaches a patient on time and within specification.

Growth Opportunity: Mastery of viral and non-viral gene transfer, process transfer to external GMP facilities, and deviation investigation builds the technical foundation for senior manufacturing scientist or process development roles.

• Process hematopoietic progenitor cell and immune effector cell products in Grade A and Grade B cleanrooms according to batch records and SOPs.
• Execute cell selection, cell culture, cryopreservation, thawing, and formulation steps in compliance with GTP/GMP regulations.
• Author and revise SOPs, master batch records, and work instructions to reflect current process and regulatory requirements.
• Review in-process cGMP documentation in real time to verify completeness and accuracy before lot release.
• Document deviations, out-of-specification events, and occurrences, then support investigation and change control to resolution.
• Monitor and qualify cleanroom environments and manufacturing equipment, completing routine quality control and preventative maintenance.
• Coordinate supply inventory and support technology transfer of manufacturing processes to internal and external GMP facilities.
• Train peers on applicable manufacturing procedures, aseptic techniques, and equipment operation.

• Bachelor's degree in biology, biotechnology, bioengineering, or medical technology, or equivalent work experience.
• 3 or more years of aseptic cell therapy manufacturing experience in a cGMP-regulated pharmaceutical or biotechnology environment.
• Demonstrated knowledge of GTP/GMP regulations, FACT and CAP standards, and FDA compliance requirements governing cell product manufacturing.
• Proficiency in aseptic and sterile technique within Grade A and Grade B cleanroom environments, including full gowning protocols.
• Experience handling and propagating human primary cells, including T cells, with competency in cryopreservation and cell culture methods.
• Ability to accurately complete batch records, deviation reports, and regulatory documentation with minimal supervision.
• Strong analytical and problem-solving skills with the ability to troubleshoot processing and equipment issues and escalate appropriately.
• Ability to work rotating shifts, off-shift hours, and weekends as operational schedules require.

• Medical Technologist (MT) certification from the American Society for Clinical Pathology (ASCP) or equivalent credential.
• Experience with viral and non-viral gene transfer techniques and closed-system cell processing platforms.
• Familiarity with flow cytometry and immunological in vitro assay methods such as ELISA and ELISpot in a manufacturing or QC context.
• Prior involvement in process optimisation projects, technology transfer activities, or validation and implementation of new manufacturing methodologies.

• Batch record accuracy rate, measured as percentage of lots released with zero documentation errors.
• Deviation closure time, reflecting how quickly investigations are completed and corrective actions implemented.
• Cleanroom environmental monitoring pass rate, tracking out-of-specification events per controlled area per quarter.
• Equipment qualification compliance rate, measuring on-time completion of preventative maintenance and qualification activities.
• SOP revision cycle time, reflecting how promptly process documents are updated following process changes or deviation findings.
• Typical tools: Cell processing platforms (commonly CliniMACS, Sepax), controlled-rate freezers, and laboratory data management systems.

• Base Salary Range: $60,000 to $85,000 per year depending on seniority and location.
• Bonus: 5 to 10 percent annual performance bonus typical in biotech manufacturing settings.
• Equity: stock options or RSUs offered at growth-stage and public biotech employers.
• Health Benefits: medical, dental, and vision coverage standard from day one.
• PTO: 15 to 20 days annually plus company-observed federal holidays.
• Common Perks: Shift differentials for off-hours work, tuition reimbursement, and professional certification support.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Background checks, including drug screening where applicable, are a condition of employment for all positions in regulated manufacturing environments. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities throughout the hiring process upon request. Candidates must be authorized to work in the United States.

The Cell Therapy Specialist owns end-to-end processing of hematopoietic progenitor cell, immune effector cell, and other cell therapy products, from cryopreservation and selection through labelling and transportation within an accredited laboratory setting. Working alongside clinical program staff and reporting to a staff supervisor, the specialist enables safe patient care by ensuring analytical testing, quality control, and regulatory compliance meet GTP/GMP, FACT, CAP, and FDA standards.

Key Responsibilities

• Process hematopoietic progenitor cell, immune effector cell, and other cell therapy products according to laboratory SOPs.
• Achieve and maintain competency in cell product cryopreservation, thawing, washing, selection/depletion, storage, labelling, and transportation.
• Process research products according to sponsor-provided manuals and internally developed processes.
• Coordinate and assist the clinical program in cell infusions.
• Comply with institutional and laboratory policies, practices, SOPs, and applicable regulations including GTP/GMP, FACT, CAP, and FDA.
• Perform daily quality control on all equipment prior to use and conduct routine preventative maintenance as required.
• Maintain patient records, both manually and computer-based.
• Document events, deviations, and occurrences and timely notify staff supervisor.
• Participate in the validation and implementation of new methodologies for cellular therapy processing and testing.

Required Qualifications

• Bachelor's degree in biology, medical technology, or a similar field of study.
• Medical Technologist (MT) certification from the American Society for Clinical Pathology (ASCP) upon hire.
• At least 2 years of relevant laboratory experience, including at least 6 months in tissue culture techniques.
• Basic understanding of cell biology and immunology.
• Ability to perform complex mathematical calculations.
• Proficiency in word processing, database, and spreadsheet programs.
• Able to work independently with minimum supervision within established SOPs and adjust to flexible or varied hours.
• Able to communicate effectively and professionally with lab staff and healthcare providers involved in patient care.

Embedded within a small manufacturing team, the Cell Therapy Specialist performs all tasks associated with clinical product manufacture following batch records and SOPs, including authoring process documents and troubleshooting equipment issues. Working closely with Process Development, Facilities, and Quality departments, the specialist advances GMP compliance and ensures right-first-time execution across cell culture and aseptic processing operations.

Core Functions

• Perform all tasks associated with the manufacture of clinical products following batch records and SOPs.
• Work as part of a small team to execute GMP runs in close collaboration with Process Development, Facilities, and Quality departments.
• Assist in the development of SOPs, master batch records, deviations, and change controls.
• Author new or revise existing SOPs, master batch records, and other process documents.
• Troubleshoot processing and equipment issues successfully.
• Review in-process cGMP documentation daily in real time for completeness and accuracy.
• Assist with change control and investigations required to manage deviations.
• Train personnel on applicable procedures and equipment.

Qualifications and Experience

• Bachelor's or master's degree plus a minimum of 3 years of relevant experience in clinical manufacturing, manufacturing sciences, or manufacturing technical support.
• Experience with cell therapy-based therapeutics such as CAR-T or other cell-based products is a plus.
• Demonstrated knowledge of pharmaceutical manufacturing, aseptic processing, and cell culture products.
• Experience handling and propagating human primary cells including T cells, with proficiency in aseptic/sterile techniques. 
• Proficiency in Microsoft Word, Excel, and data analysis.
• Self-motivated, detail-oriented, with excellent interpersonal, verbal, and written communication skills.
• Able to work off-shift hours and weekends as needed, and adapt to changing priorities with minimal direction.

Reporting to the Quality Assurance and Quality Control team, the Cell Therapy Specialist performs manufacturing of clinical and commercial products in B, D, and C grade areas following batch records and SOPs, covering deviation management, SOP optimisation, and cleanroom maintenance. Partnering with Product Sciences and Material Management, this specialist contributes to consistent, high-quality output and ongoing process improvement across a state-of-the-art manufacturing facility.

Primary Duties

• Perform tasks associated with the manufacturing of clinical and commercial products following batch records and SOPs in B, D, and C grade areas.
• Work as part of a dedicated team to execute GMP runs in collaboration with Product Sciences, Material Management, and Quality Assurance and Quality Control.
• Assist in optimisation of SOPs and batch records and revise existing manufacturing batch records, SOPs, and work instructions to support process improvements and GMP compliance.
• Assist in investigations required to manage deviations and in managing change controls.
• Comply strictly with SOPs and cGMP regulations and accurately complete documentation associated with clinical and commercial manufacturing.
• Ensure consistent process execution to guarantee high quality output.
• Maintain cleanroom in an optimal state.
• Continuously look for improvements to processes to increase quality and efficiency.

Skills and Qualifications

• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products.
• Skilled in Microsoft Word, Excel, and data analysis.
• Experience working in a fast-paced, growing company environment with the ability to adjust workload based on changing priorities.
• Comfortable working with full gowning requirements in a completely aseptic environment, including in a brand new state-of-the-art manufacturing plant.
• Passionate about following SOPs with curiosity and interest in continuous learning and growth.
• Excellent interpersonal, verbal, and written English communication skills.
• Good judgment, problem-solving, and analytical skills, with willingness to work in shifts and accommodate schedule adjustments.

Sitting at the intersection of process development and GMP manufacturing, the Manufacturing Cell Therapy Specialist develops and transfers next-generation cell manufacturing processes to internal and external GMP facilities, performing aseptic production, cell selection, viral and non-viral gene transfer, and cryopreservation. Operating across Process Development, warehouse management, and quality functions, the specialist shapes manufacturing outcomes by authoring SOPs, qualifying equipment, and training peers in a regulated cleanroom environment.

Duties

• Perform aseptic production of cell-based products in clean rooms in compliance with manufacturing instructions and GMP regulations.
• Perform cell selection, cell culture, viral and non-viral gene transfer, and cryopreservation.
• Support evaluation and implementation of process optimisation and provide troubleshooting assistance during deviations.
• Monitor and qualify clean room and equipment.
• Support warehouse management and coordinate supply inventory.
• Train peers and other manufacturing employees in manufacturing processes as needed.
• Author and execute SOPs and batch records.
• Document and analyse data.

Experience and Qualifications

• Bachelor's degree or equivalent qualification (BTA/PTA/MTA/CTA/BSc) in biology, biotechnology, bioengineering, or medical technology.
• Minimum of 3 years' experience in aseptic manufacturing of human cell products.
• Strong knowledge of sterile cell culture techniques such as cell passaging, cryopreservation, and formulation of media.
• Cell therapy manufacturing experience in a GMP-regulated environment preferred.
• Experience with common cell processing devices such as CliniMACS, closed system cell washers, bioreactors, and controlled-rate freezers is a plus.
• Experience with flow cytometry and immunological in vitro assays such as ELISA and ELISpot is desirable.
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
• Fluent in German with good English skills, both oral and written.
• Ability to work independently and in a team setting with high understanding of quality and responsibility.

A key member of the chronic pain therapies field team, the Cell Therapy Specialist provides technical, clinical, and programming assistance to 1-2 Territory Managers, supporting case coverage, customer education, and in-service training across implantable device accounts. Collaborating across sales, clinical, and regional teams, the specialist builds high-trust customer relationships that enable Territory Managers to increase selling time and drive adoption of Abbott chronic pain therapies products.

Accountabilities

• Provide technical, clinical, and programming assistance primarily in support of 1-2 Territory Managers.
• Assist Territory Managers in after-hours call support and activities.
• Integrate into all accounts and build trust and rapport with customers.
• Conduct proficient complex programming and case support.
• Foster high-trust relationships with customers, including regional team members.
• Conduct PCP work and educational in-services as directed.
• Develop and maintain in-depth knowledge of assigned accounts, customers, and competitor activity.
• Conduct evaluations and develop sales strategies for capital equipment opportunities within accounts.
• Provide feedback to providers on directions for use specific to implantable devices.
• Attend trade shows and conferences to discuss new product developments as needed.

Education and Experience

• Bachelor's degree preferred, with an associate's degree or technical certification as a minimum.
• 1-2 years of work experience, with strong preference for patient-facing clinical settings.
• 1-3 years of experience with Abbott or in a spinal cord stimulation or implantable medical device setting preferred.
• Ability to communicate, understand, and educate clinical data in the chronic pain therapies space, with strong clinical skills.
• Excellent organisational, time management, and prioritisation skills.
• Excellent interpersonal, verbal, written, and presentation skills with the ability to communicate effectively at multiple levels and to large groups.

Consistent post-sales performance and new deal closure depend on the Cell Therapy Specialist, who partners with a Territory Manager to demonstrate Fujifilm Sonosite ultrasound products, implement solutions at customer sites, and drive product adoption across installed base accounts. Serving as the primary commercial resource in the absence of the Territory Manager, this specialist supports Inside Sales Representatives and cross-functional stakeholders to ensure a positive, ongoing customer experience.

Key Deliverables

• Partner with the Territory Manager to understand prospect clinical needs, demonstrate products, and close new deals.
• Implement products at customer sites and train customers on how to use new products.
• Own post-sales activities in the field, including encouraging product adoption and addressing customer issues.
• Maintain presence and relationships at installed base client sites.
• Convey the overall value of products for users and stakeholders within customer sites.
• Work with Inside Sales Representatives to demonstrate products in the field as needed.
• Identify upsell and cross-sell opportunities within existing customers and bring them to the Territory Manager.
• Provide clinical, technical, and educational support to new and existing customers as needed.
• Act as primary commercial resource in the absence of the Territory Manager.

Background and Experience

• Associate's degree from an accredited ultrasound teaching institution.
• RDMS certification in Abdomen/OB GYN required, RDCS or RDCS-eligible and RVT or RVT-eligible preferred.
• At least 3 years of experience in diagnostic ultrasound including abdominal, OB/GYN, and vascular.
• Ability to understand both the clinical and business needs of the customer and translate them into clear product requests.
• Ability to develop and maintain positive customer relationships and manage interpersonal relationships with team members and colleagues professionally.
• Ability to adapt to changing priorities and workloads, work in an organised manner, and meet deadlines consistently.

As the Cell Therapy Specialist, this role troubleshoots processing and equipment issues, authors and revises SOPs aligned with cGMP requirements, and operates sophisticated automated cell processing and filling equipment in Grade B/C clean rooms. The manufacturing team relies on this work to maintain compliance, identify efficiency improvements, and support investigations and change controls across a pharmaceutical or biotechnology manufacturing environment.

Areas of Ownership

• Troubleshoot processing and equipment issues successfully and communicate them to management.
• Complete required training assignments to maintain technical skills and ensure compliance with cGMP requirements.
• Author and/or revise SOPs that are technically sound, provide clear instructions aligned with cGMP requirements, and support efficient operations.
• Monitor, clean, prepare, and operate sophisticated automated cell processing, expansion, and filling equipment in Grade B/C clean rooms.
• Identify opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations, deviations, and change controls.

Professional Experience

• 3 or more years of cGMP experience in a pharmaceutical, biotechnology, or similar manufacturing environment.
• Experience in handling and propagating human primary cells including T cells, with previous experience in cell therapy or vector products preferred.
• Confirmed knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and cell culture and/or vector products, with excellent aseptic/sterile techniques in Grade A and Grade B clean rooms.
• Experience with automated processing equipment and cell culture processing.
• Proficiency in Microsoft Word, Excel, and data analysis.
• Ambitious and willing to accept temporary responsibilities outside of the initial job description, comfortable in a fast-paced environment with the ability to adjust to changing priorities.
• Excellent interpersonal, verbal, and written communication skills, with the ability to work off-shift and extra hours as required.

Cell Therapy Specialist delivers territory sales results across cell and gene therapy product lines, developing account strategies and business plans in close partnership with high-level decision makers across translational and industrial customer organisations. The work directly supports portfolio growth in immunology, stem cells, bioreactors, and cryopreservation markets by combining scientific expertise with a collaborative, cross-functional selling approach.

Job Functions

• Achieve and exceed territory sales goals across key product areas within the cell therapy product lines.
• Develop specific account strategies, account portfolios, and territory business plans by working with high-level decision makers in customer organisations.
• Actively adjust plans to meet local dynamic situations.
• Operate effectively in a multi-tasking, dynamic environment while maintaining a customer-first attitude.
• Utilise internal resources and complementary product portfolios effectively in a collaborative, cross-functional team selling environment.
• Present product and application solutions formally to a technical audience.

Knowledge Skills and Abilities

• Bachelor's, master's degree, or greater in sciences such as biology, bioengineering, chemistry, medicine, or immunology.
• 3 years of proven relevant sales experience in laboratory or related fields.
• Experience working in environments focused on immunology, cord blood, stem cells, immunotherapy, cell therapy, viral vectors, gene therapy, cell culture, bioreactors, or cryopreservation, with sales experience in these areas preferred.
• Experience with biotechnology and pharmaceutical industries focused on life sciences research and GMP manufacturing.
• Ambitious self-starter with a proven track record of meeting sales goals, strong collaborative behaviour, and good negotiating skills.
• Excellent communication skills with the ability to present effectively to technical audiences.