Associate Scientist II, Analytical Research & Development

About Site St. Petersburg: 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 provide diversification and offerings that increase speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. The 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 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 traditional animal-based gelatin softgels, the site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.

About the role

Perform analytical testing on various materials and products, ensuring compliance with established methods and regulatory standards. Conduct chromatographic analyses, prepare necessary reagents, and maintain accurate documentation. Author technical documents, support laboratory operations, and contribute to process improvements while ensuring safety and quality standards are met.

Shift: Standard Hours, Monday through Friday
Location: St. Petersburg, FL – 100% Onsite

Responsibilities

• 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.

Requirements

• Minimum of an 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 a 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.
• Expertise in wet chemistry techniques such as titrations and extractions as per compendia.
• Familiarity with separation chromatographic instruments such as High-Performance Liquid Chromatography (HPLC)/Ultra-High-Performance Liquid Chromatography (UHPLC) and Gas Chromatography (GC).
• Ability to sit, stand, walk regularly and occasionally lift 0-20 pounds.
• Vision requirements: 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.

Preferred Skills

• Familiarity with pharmaceutical software such as Laboratory Information Management System (LIMS), TrackWise, and Empower.

Benefits

• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement – support to finish your degree or earn a new one.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement initiatives including regular Beach Clean-up participation.
• Defined career path and annual performance review and feedback process with potential for career growth on an expanding team.
• WellHub program to promote overall physical and mental wellness.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.