Biological Scientist II-Department of Neurosurgery-GMP Lab

University of Florida • Gainesville, FL

1d • Onsite

About The Position

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.

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.
• Strict adherence to written protocols.
• Meticulous reporting and data entry.
• Strict adherence to written SOPs.
• Accuracy and attention to detail.
• Strong organizational skills.
• Proficient in Microsoft Office (Excel and Word).
• Reliable.
• Excellent communication skills.

Nice To Haves

• 3+ years of related experience
• Working understanding of Cell Therapy concepts
• Experience with EM equipment
• Experience working in cGMP environment

Responsibilities

• Manufacturing clinical trial products in a cleanroom environment in compliance with GMP regulations and SOPs.
• Performing EM of both the Human Applications Lab and the Cancer and Genetics GMP Facilities.
• Monitoring non-viable airborne particles and viable airborne particulates, surface monitoring, and personnel monitoring.
• Maintaining the laboratory and equipment in clean and working conditions in compliance with GMP standards.
• 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.
• Keeping protocols and chemicals inventory up-to-date.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level