Biological Scientist II-GMP Lab

University of Florida•Gainesville, FL

5d•Onsite

About The Position

This role involves executing cell processing procedures in accordance with approved SOPs, batch records, and GMP requirements. Responsibilities include performing aseptic processing, cell culture, expansion, cryopreservation, thawing, and formulation activities. The position also requires preparing reagents, materials, and equipment for manufacturing runs, and maintaining cleanroom standards, gowning compliance, and contamination control practices. Additionally, the role involves accurately completing batch records, logbooks, and GMP documentation contemporaneously, participating in deviation reporting, CAPA support, and change control implementation, and maintaining compliance with cGMP, institutional, and regulatory requirements. The Biological Scientist II will also record and maintain detailed research procedures and results, follow Good Documentation Practices (GDP), and participate in training activities for co-workers and junior staff. Quality control responsibilities include performing analytical testing for cell therapy product release such as flow cytometry, ELISA, endotoxin, and Gram Stains, assisting with in-process monitoring and sample preparation, and analyzing resulting data using statistical models to ensure product quality and process consistency. Test results must be documented and traceability ensured in compliance with GMP requirements.

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
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
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

Nice To Haves

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

Responsibilities

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
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
Record and maintain detailed research procedures and results
Follow Good Documentation Practices (GDP) and maintain audit-ready records
Participate in training activities for co-workers and junior staff
Perform scheduled tasks requiring strict adherence to SOPs with meticulous reporting and data entry
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