Manufacture Tech I-Department of Neurosurgery-GMP

University of Florida•Gainesville, FL

13d•Onsite

About The Position

This position is for a Biological Scientist I in the Department of Neurosurgery, focusing on GMP (Good Manufacturing Practices). The role involves performing analytical testing of Phase I immunotherapy drug substance and drug product, adhering strictly to written procedures and documentation practices with a high degree of accuracy and consistency. The individual will maintain compliance with GLP, GMP, and internal quality system requirements, manage sample receipt, tracking, storage, and documentation, and accurately complete records to support data integrity and traceability. Additionally, the role supports the environmental monitoring program within the GMP facility, maintains laboratory inventory, and ensures QC laboratory spaces are clean and organized. Collaboration with cross-functional teams such as Manufacturing, Facilities, and Quality Assurance is expected to support GMP operations and clinical manufacturing activities.

Requirements

Bachelor's degree in biology or a closely related life science field.
Foundational knowledge of cellular and molecular biology principles.
Proficient in standard laboratory techniques and analytical methods.
Skilled in following detailed protocols within regulated environments.
Strong organizational abilities with high attention to detail.
Effective written and verbal communication skills.
Experienced in documentation and accurate record-keeping.
High accuracy and attention to detail.
Strong organizational and time management skills.
Proficient in Microsoft Office (Excel, Word).
Dependable and consistent in task execution.
Clear and professional communication.
Must be able to lift heavy boxes (approximately 50 lbs).

Nice To Haves

Performed cell-based and molecular assays with attention to accuracy and reproducibility.
Worked in regulated laboratory environments, including GMP/GLP settings.
Supported sample management, inventory control, and daily laboratory operations.
Maintained organized records while effectively managing multiple tasks and priorities.

Responsibilities

Perform analytical testing of Phase I immunotherapy drug substance and drug product according to approved procedures and test methods.
Adhere strictly to written procedures, protocols, and documentation practices with a high degree of accuracy and consistency.
Maintain compliance with applicable GLP, GMP, and internal quality system requirements.
Manage sample receipt, tracking, storage, and documentation in accordance with established procedures.
Accurately complete records, logs, and other controlled documentation to support data integrity and traceability.
Support the environmental monitoring program within the GMP facility.
Maintain laboratory inventory, including reagents, consumables, and test materials.
Maintain QC laboratory spaces in a clean, organized, and inspection-ready state.
Collaborate with cross-functional teams including Manufacturing, Facilities, and Quality Assurance to support GMP operations and clinical manufacturing activities.