Senior Scientist, Quality Control

St. Petersburg is 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 Senior Scientist, Quality Control to join our team. In this role, you will perform testing and release of materials and products in accordance with approved methods and regulatory standards. You will conduct microbiological, environmental, and analytical testing while ensuring compliance with cGMP and data integrity requirements. You will also support method development, validation, and technology transfers, while providing technical guidance and maintaining laboratory operations.

This position offers the chance to contribute to high-quality manufacturing and continuous improvement initiatives.

Shift: Standard Hours, Monday through Friday

Location:

St. Petersburg, FL
100% Onsite

• Perform testing and release of raw materials, in-process materials, intermediates, finished products, validation samples, and non-routine products in accordance with approved methods, specifications, and compendial requirements.
• Conduct microbiological testing, including cultivation and identification of bacteria and other microorganisms using selective and non-selective media, Gram staining, API, and other applicable techniques.
• Perform environmental and utility testing, including purified and potable water, compressed gases, manufacturing environmental monitoring, moisture testing, cleaning validation, and process validation support.
• Develop, modify, validate, and implement analytical testing procedures, assays, methods, and technologies; support new product qualifications, method transfers, and technology transfers.
• Analyze, interpret, and document results; perform statistical analyses; maintain laboratory notebooks, logbooks, reports, and LIMS records in compliance with cGMP, SOPs, data integrity standards, and regulatory requirements.
• Review and audit calculations, analytical data, and test results for accuracy and compliance; release samples through LIMS to Quality Assurance for final product disposition.
• Provide technical support, training, and work direction to scientists, analytical chemists, and laboratory technicians; assist with scheduling, internal audits, continuous improvement initiatives, and laboratory operations.
• Maintain laboratory equipment, supplies, cultures, reagents, standards, and media; ensure safe handling of potent and teratogenic compounds, proper hazardous waste disposal, and compliance with FDA, EPA, OSHA, and internal safety requirements.
• Work flexible hours, including evenings and weekends, as needed to support manufacturing and validation schedules.

• Bachelor’s degree in Science or a related field required, preferably Chemistry, Microbiology, or Biology.
• 8 years of analytical laboratory experience required.
• Hands-on experience with UV spectroscopy, infrared spectroscopy, atomic absorption, high-performance liquid chromatography, gas chromatography, and dissolution testing.
• Proficiency in wet chemistry techniques, including titrations, extractions, digestions, and preparation of test solutions; experience with autoclaves and Vitek systems.
• Strong…