Scientist II, Quality Control - Microbiology

Catalent seeks a Scientist II in Quality Control Microbiology for their St. Petersburg softgel manufacturing facility. The role involves performing microbiological testing of raw materials, in-process materials, and finished products according to cGMP standards, with responsibility for environmental monitoring, data integrity, and laboratory investigations.

Responsibilities

• Perform microbiological testing of raw materials, in-process materials, finished products, and stability samples per approved methods
• Conduct environmental monitoring of manufacturing areas, utilities, and water systems with statistical trending
• Cultivate, isolate, and characterize bacteria, yeast, and mold; maintain reference cultures and test organisms
• Initiate and write laboratory investigations for excursions, deviations, and invalid test results; evaluate root cause
• Prepare microbiological media, reagents, and test organisms; support method validation and qualification activities

Requirements

• Bachelor's degree in Microbiology, Biology, Biological Sciences, or related life-science discipline
• Minimum eight years of microbiology experience in pharmaceutical, biotechnology, dietary supplement, or regulated laboratory
• Extensive hands-on experience with USP <60> , <61> , <62> and nonsterile pharmaceutical product testing
• Demonstrated proficiency in environmental monitoring, viable air/surface sampling, and statistical data trending
• Strong technical writing skills with experience developing and revising SOPs, methods, and investigations
• Knowledge of bacterial, yeast, and mold isolation, characterization, and reference culture maintenance
• Ability to pass Ishihara Color Vision Screening and achieve 20/30 acuity in far and near vision