Scientist II, Quality Control - Microbiology

Catalent • Saint Petersburg, FL

1d • Onsite

About The Position

The Scientist II, Quality Control - Microbiology performs microbiological testing of raw materials, in-process materials, finished products, stability samples, and validation samples under approved methods and procedures. The role supports environmental monitoring, method suitability, and data integrity in compliance with cGMP standards. It is a hands-on laboratory position requiring technical expertise and attention to detail.

The position is based 100% onsite in St. Petersburg, Florida, with standard Monday-through-Friday hours. The Scientist conducts testing and investigations, documents and reviews results in LIMS and other electronic systems, and prepares or revises procedures and technical documents. The role also supports equipment qualification, training, audits and inspections, laboratory safety, inventory, and special projects, working independently with minimal supervision.

The St. Petersburg site is Catalent’s primary softgel development and manufacturing facility in North America. Its capabilities include formulation development, analytical services, routine quality control testing, stability studies, and manufacturing across multiple product types and markets.

Requirements

• Bachelor of Arts or Bachelor of Science with college coursework in Microbiology, Biology, Biological Sciences, or a related life-science discipline.
• At least eight years of experience in a microbiology, pharmaceutical, biotechnology, dietary supplement, or other regulated laboratory environment.
• Extensive hands-on cGMP laboratory experience testing raw materials and finished products, including preparatory testing, method suitability, recovery assessments, microbial enumeration, and specified microorganism testing.
• Strong working knowledge and hands-on experience with USP <60>, USP <61>, and USP <62>.
• Experience with environmental monitoring, including viable air and surface monitoring, and ability to statistically trend environmental monitoring data using approved software and communicate meaningful trends and emerging adverse conditions.
• Experience testing pharmaceutical water systems and manufacturing utilities; aseptic microbiological laboratory techniques; preparing and handling media, reagents, diluents, neutralizers, and test organisms; growth promotion testing; reference culture handling; and autoclave and sterilization practices.
• Knowledge of bacterial, yeast, and mold recovery, isolation, and preliminary characterization, plus experience coordinating isolate identification through qualified contract laboratories, including handling, documentation, shipment, and review of identification results.
• Extensive experience conducting and writing microbiological laboratory investigations, including excursions, deviations, atypical results, and invalid tests; ability to evaluate root cause and support appropriate corrective and preventive actions.
• Strong technical writing skills and demonstrated experience writing or revising SOPs, microbiological test methods, protocols, investigations, and technical reports.
• Ability to differentiate color and pass the Ishihara Color Vision Screening; ability to obtain 20/30 far and near visual acuity in both eyes, with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is identifying at least 4 of 6 numbers in the circles.
• Ability to work extended hours or off-hours as required.

Nice To Haves

• Experience testing nonsterile pharmaceutical products is strongly preferred.
• Experience writing laboratory investigations and performing USP preparatory testing and qualification for chapters <61> and <62> is strongly preferred.

Responsibilities

• Perform microbiological testing of raw materials, in-process materials, finished products, stability samples, and validation samples according to approved methods, procedures, protocols, specifications, and compendial requirements.
• Conduct preparatory testing, method suitability, and nonsterile product testing in accordance with USP <60>, USP <61>, and USP <62>, including sample preparation, dilution, neutralization, recovery, and testing conditions.
• Test purified and potable water, compressed gases, manufacturing areas, utilities, and environmental samples; conduct environmental monitoring and statistically trend environmental monitoring data.
• Cultivate, recover, and isolate bacteria, yeast, and mold, and perform preliminary characterization including Gram staining and colony morphology; maintain stock and reference cultures and challenge organisms.
• Prepare microbiological media, reagents, diluents, neutralizers, and test organisms; support growth promotion testing, method transfers, suitability, verification, qualification, and validation activities.
• Interpret, document, and report microbiological results in LIMS and other electronic laboratory systems.
• Perform technical review and auditing of calculations, test records, data, and reports for accuracy, cGMP compliance, and data integrity.
• Initiate, conduct, and write laboratory investigations for microbiological excursions, atypical results, deviations, invalid tests, and environmental monitoring events; evaluate root cause and support corrective and preventive actions.
• Write and revise SOPs, methods, protocols, investigations, and technical reports.
• Support equipment qualification, training, audits and inspections, laboratory safety, inventory, and special projects while working independently with minimal supervision.
• Perform other duties as assigned.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Employee Resource Groups focused on diversity and inclusion.
• WellHub program promoting physical and mental wellness.
• Perkspot discounts from approximately 900 or more merchants.
• Defined career path and annual performance review and feedback process, with potential for career growth.

What This Job Offers

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