The GMP Cell Processing Manufacturing Technician within the Department of Neurosurgery is responsible for performing specialized manufacturing activities that support the production of GMP-compliant cell therapy products. This position executes aseptic cell processing procedures, including cell culture, expansion, cryopreservation, thawing, and formulation, while maintaining strict adherence to cGMP regulations, cleanroom standards, and contamination control practices. The incumbent prepares materials, equipment, and reagents for manufacturing operations, performs quality control and analytical testing, and maintains accurate GMP documentation, including batch records, deviations, and change control documentation in accordance with Good Documentation Practices (GDP). This role ensures product quality, regulatory compliance, and operational efficiency while supporting the successful manufacture of clinical-grade cell therapy products.The Lillian S. Wells Department of Neurosurgery at the University of Florida, College of Medicine is committed to providing comprehensive clinical services for the diagnosis, management, treatment, and rehabilitation of patients suffering from diseases of the brain, spinal cord, and nervous system, including brain tumors, aneurysms, stroke, epilepsy, functional disorders, and spinal disorders and injuries. Our clinical care mission also extends throughout North Central Florida through regional neurosurgery programs. We offer the full spectrum of neurosurgical and neuro-oncology treatment options for both adults and pediatric patients. Our research labs and investigator-led initiatives and clinical trials are developing promising new treatments for neurological diseases that are extremely difficult to treat with conventional therapies. The Department of Neurosurgery offers education and training programs such as ACGME-accredited neurosurgery residency programs and fellowship programs.
| Classification Title: | Biological Scientist II |
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| Classification Minimum Requirements: | Bachelor's degree in biology or a related field and three years of experience or Master's degree in biology or a related field with one year of relevant experience. |
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| Job Description: | Manufacturing & Processing
Execute cell processing procedures in accordance with approved SOPs, batch records, and GMP requirements
- Perform aseptic processing, cell culture, expansion, cryopreservation, thawing, and formulation activities.
- Prepare reagents, materials, and equipment required for manufacturing runs.
- Maintain cleanroom standards, gowning compliance, and contamination control practices.
Documentation & Compliance
- Accurately complete batch records, logbooks, and GMP documentation contemporaneously. Participate in deviation reporting, CAPA support, and change control implementation. Maintain compliance with cGMP, institutional, and regulatory requirements.
- Participate in deviation reporting, CAPA support and change control implementation.
- Record and maintain detailed research procedures and results.
- Maintain compliance with cGMP, institutional, and regulatory requirements.
- Follow Good Documentation Practices (GDP) and maintain audit-ready records.
Training
- Participate in training activities for co-workers and junior staff.
- Perform scheduled tasks requiring strict adherence to SOPs with meticulous reporting and data entry.
Quality Control & Analytical Testing
- Perform analytical testing for cell therapy product release including flow cytometry, ELISA, endotoxin, Gram Stains and related assays.
- Assist with in-process monitoring and sample preparation.
- Analyze resulting data using statistical models to ensure product quality and process consistency.
- Document test results and ensure traceability in compliance with GMP requirements.
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| Expected Salary: | $61,350-$69,700 |
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| Required Qualifications: | Bachelor's degree in biology or a related field and three years of experience or Master's degree in biology or a related field with one year of relevant experience. |
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| Preferred: | -Prior experience in small- to intermediate-scale cell therapy manufacturing under GMP conditions strongly preferred.
- Familiarity with autologous cell therapy manufacturing workflows is highly desirable.
-Experience with aseptic technique in ISO-classified cleanroom environments.
-Working knowledge of cGMP regulations and documentation practices.
-Understanding of Quality Control processes and basic analytical testing methods.--Experience with flow cytometry, cell counting systems, or other cell-based analytical assays is a plus.
-Prior hands-on experience in clinical-stage cell therapy manufacturing under GMP conditions.
-A working understanding of quality control principles, and basic analytical testing skills to support in-process monitoring and product release activities.
Skills:
-Strong aseptic technique.
-High attention to detail and documentation accuracy.
-Ability to follow complex written procedures precisely.
-Understanding of chain-of-identity and chain-of-custody principles-Team-oriented with strong communication skills.
-Ability to work in a fast-paced clinical manufacturing environment.
-Proficient in Office Suite software.
PHYSICAL QUALIFICATIONS:
-Must be able to lift heavy boxes (approximately 50 lbs)
-Must be in good physical condition to clean the GMP facilities on a regular basis |
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| Special Instructions to Applicants: | For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references. Application must be submitted by 11:55 p.m. (ET) of the posting end date. |
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| Health Assessment Required: | Yes |
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