Associate Scientist II, Analytical Research & Development

About Site

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 OTC, prescription, 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, the 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 an Associate Scientist II, Analytical Research & Development to join our team. In this role, you will perform analytical testing on various materials and products, ensuring compliance with established methods and regulatory standards. You will conduct chromatographic analyses, prepare necessary reagents, and maintain accurate documentation. This position also involves authoring technical documents, supporting laboratory operations, and contributing to process improvements while ensuring safety and quality standards are met.

Shift: Standard Hours, Monday through Friday

Location:

St. Petersburg, FL

100% Onsite

• Perform compendial and non‑compendial analytical testing on raw materials, in‑process samples, drug substances, cleaning samples, stability samples, and finished products in accordance with established methods.
• Conduct chromatographic analyses, including assay, content uniformity, dissolution, and other single‑analyte testing while accurately documenting and interpreting results in compliance with current Good Manufacturing Practice (cGMP) requirements.
• Prepare reagents, standards, media, and mobile phases to support laboratory testing and maintain laboratory notebooks, reports, and records in accordance with standard operating procedures (SOPs) and regulatory requirements.
• Author and review analytical methods, specifications, protocols, SOPs, deviations, and other technical documentation to support laboratory operations and continuous improvement initiatives.
• Ensure right‑first‑time execution of laboratory procedures while maintaining compliance with Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and internal quality and safety standards, including proper handling of potent compounds and hazardous waste.
• Support material evaluation activities for new materials, assist with laboratory operations, and contribute to process improvements and cross‑functional departmental initiatives.
• Communicate analytical findings through written reports and verbal presentations, stay current with scientific literature, and assist in training colleagues on laboratory procedures and best practices.

• Associate’s degree in science with 10 or more years in an analytical laboratory, including 5 years in a Good Manufacturing Practice (GMP) environment, or
• Bachelor’s degree in science with 3 or more years in a GMP analytical laboratory.
• Experience with common pharmaceutical equipment: UV/VIS, infrared (IR), atomic absorption (AA), and dissolution required.
• Expertise in wet chemistry techniques such as titrations and extractions as per compendia required.
• Familiar with separation chromatographic instruments such as high‑performance liquid…