Scientist, Quality Control

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.

Position Summary

We have an opportunity for a Scientist, Quality Control to join our team. In this role, you will perform microbiological and analytical testing of finished products, raw materials, and validation samples. You will also conduct environmental and utility testing, maintain microbial cultures, and prepare necessary reagents and materials. This position involves interpreting and documenting results, supporting laboratory equipment activities, and ensuring compliance with GMP and safety requirements.

Shift: Standard Hours, Monday through Friday

Location:

St. Petersburg, FL 100% Onsite

Perform microbiological and analytical testing of finished products, raw materials, in-process materials, and validation samples according to approved methods, protocols, and compendia.

Conduct environmental and utility testing, including water, compressed gases, manufacturing environments, moisture, and cleaning/process validation support.

Cultivate, isolate, and identify microorganisms using selective and non-selective media, Gram staining, API, and other identification techniques.

Maintain microbial cultures in accordance with ATCC requirements and departmental Standard Operating Procedures.

Prepare reagents, standards, media, and other materials required for laboratory testing.

Interpret, document, and enter analytical results into approved notebooks, reports, logbooks, and the LIMS database.

Support laboratory equipment activities, including qualification (Installation Qualification/Operational Qualification/Performance Qualification), training, preventive maintenance, calibration, troubleshooting, and repairs.

Follow Good Manufacturing Practices, safety, regulatory, and environmental requirements, including hazardous/DEA waste handling and working with potent or teratogenic compounds; serve as Senior Scientist Designee when needed.

Other duties as assigned.

• Bachelor of Arts or Bachelor of Science with college coursework in related sciences.
• 5+ years of experience in an analytical laboratory.
• Good interpersonal skills.
• Ability to effectively communicate with co-workers.
• Strong organizational skills.
• Experience with Infrared and Atomic Absorption instrumentation.
• High-Performance Liquid Chromatography and Gas Chromatography instrumentation experience.
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Be accessible to manufacturing, laboratory, and office staff.
• Ability to use required office equipment.
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent's in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Ability to work extended hours or off-hours as required.

• Experience with Ultraviolet spectroscopy.
• Experience with Infrared and Atomic Absorption instrumentation.
• High-Performance Liquid Chromatography and Gas…