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Biological Scientist II-Department of Neurosurgery-GMP Lab

University of Florida

Gainesville, FL

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JOB DETAILS
SKILLS
Biology, Cardiovascular Disease, Cerebral Vascular Accident, Cleanroom, Clinical Facilities, Clinical Medicine, Clinical Monitoring, Clinical Trial, Communication Skills, Current Good Manufacturing Practice (cGMP), Data Entry, Detail Oriented, Disease, Disease Treatment, Environmental Compliance, Environmental Health, Environmental Monitoring, Fellowship, Forestry and Logging Machinery, GMP (Good Manufacturing Practices), Hazardous Materials Clean-Up, Hazardous Materials/Substances, Heavy Lifting, Inventory Management, Laboratory Equipment, Manufacturing, Medical Products, Medical Treatment, Medicine, Microsoft Excel, Microsoft Office, Microsoft Word, Neurology, Neurosurgery, Oncology, Organizational Skills, Pediatrics, Quality Assurance, Quality Control, Quality Management, Regulations, Regulatory Compliance, Research Laboratory, Safety/Work Safety, Spinal Cord Injury, Standard Operating Procedures (SOP), Training Program, Training/Teaching
LOCATION
Gainesville, FL
POSTED
3 days ago
The Biological Scientist II will support the Manufacturing and Quality Control teams in a cGMP facility by producing clinical-grade cell therapy products and conducting environmental monitoring during clinical manufacturing. All work must follow current Good Manufacturing Practice (cGMP) regulations. Additional duties include inventory tracking, maintaining clean and functional lab facilities and equipment, and logging samples and materials using SOPs. The position reports to the Quality Control Manager and Assistant Director of Operations, collaborates with the cGMP team, and is subject to training, review, and oversight by the Quality Assurance unit of the CTSI.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

Classification Minimum Requirements:Bachelor's degree in biology or a closely related field and three years of relevant experience; or a Master's degree in biology or a closely related field and one year of relevant experience; Doctoral degree in biology or a closely related field.
Job Description:

Manufacturing clinical trial products in a cleanroom environment in compliance with GMP regulations and SOPs.  This activity requires strict adherence to written protocols as well as meticulous reporting and data entry.

Performing EM of both the Human Applications Lab and the Cancer and Genetics GMP Facilities.  This includes monitoring non-viable airborne particles and viable airborne particulates, surface monitoring, and personnel monitoring.  These tasks are performed on a scheduled basis, require strict adherence to written SOPs, and also require meticulous reporting and data entry.  The operating status of the cleanroom facilities will depend on the data obtained from EM after review by the QC Manager and Quality Management.

Maintaining the laboratory and equipment in clean and working conditions in compliance with GMP standards including, but not limited to, inventory tracking and ordering, maintaining proper inventory in compliance with GMP and Environmental Health & Safety (EH&S) regulations, logging in samples and reagents/materials, overseeing hazardous waste disposal, and keeping protocols and chemicals inventory up-to-date.

Expected Salary:

Salary commensurate with education and experience.

Required Qualifications:Bachelor's degree in biology or a closely related field and three years of relevant experience; or a Master's degree in biology or a closely related field and one year of relevant experience; Doctoral degree in biology or a closely related field.
Preferred:

EXPERIENCE
- 3+ years of related experience

KNOWLEDGE
- Working understanding of Cell Therapy concepts
- Experience with EM equipment
- Experience working in cGMP environment

SKILLS
- Accuracy and attention to detail
- Strong organizational skills
- Proficient in Microsoft Office (Excel and Word)
- Reliable
- Excellent communication skills

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

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. 

This requisition has been reposted. Previous applicants are still under consideration and need not apply.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:Yes

 

About the Company

U

University of Florida