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Biological Scientist II-GMP Lab

University Of Florida

Job Location:

Gainesville, FL - USA

Monthly Salary: $ 61350 - 69700

Posted: 8 August 2026 (27 days ago)

Application Deadline: 5 November 2026

Vacancies: 1 Vacancy

Job Summary

Classification Title:	Biological Scientist II
Classification Minimum Requirements:	Bachelors degree in biology or a related field and three years of experience or Masters degree in biology or a related field with one year of relevant experience.
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.
Expected Salary:	$61350-$69700
Required Qualifications:	Bachelors degree in biology or a related field and three years of experience or Masters degree in biology or a related field with one year of relevant experience.
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
Special Instructions to Applicants:	For consideration please complete an application and include a cover letterresumeand 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.
Health Assessment Required:	Yes