Scientist II, Quality Control - Microbiology

About Site St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic.

Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St.

Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based Opti Shell® and Vegicaps® to expand the range of molecules that can be encapsulated.

We have an opportunity for a Scientist II, Quality Control
- Microbiology to join our team. The role involves performing microbiological testing of raw materials, in-process materials, finished products, stability, and validation samples according to approved methods and procedures. The position supports environmental monitoring, method suitability, and data integrity in compliance with cGMP standards. This is a hands‑on laboratory role requiring strong technical expertise and attention to detail.

Shift: Standard Hours, Monday through Friday

Location:

St. Petersburg, FL 100% Onsite

• Perform microbiological testing of raw materials, in-process materials, finished products, stability, 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 , USP , and USP , including sample preparation, dilution, neutralization, recovery, and testing conditions.
• Perform microbiological testing of purified/potable water, compressed gases, manufacturing areas, utilities, and environmental samples; conduct environmental monitoring and statistical trending of EM data.
• Cultivate, recover, isolate, and perform preliminary characterization of bacteria, yeast, and mold, including Gram staining and colony morphology; maintain stock/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/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/preventive actions.
• Write and revise SOPs, methods, protocols, investigations, and technical reports; support equipment qualification, training, audits/inspections, laboratory safety, inventory, and special projects while working…