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Saint Petersburg, Florida, United States
Onsite
Associate Scientist II, Analytical Research & Development
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 OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.
Position Summary
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
The Role
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.
The Candidate
Minimum Requirements
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 Chromatography (HPLC)/Ultra-High-Performance Liquid Chromatography (UHPLC) and Gas Chromatography (GC) required.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds.
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.
Preferred Skills & Background
Familiar with pharmaceutical software such as Laboratory Information Management System (LIMS), TrackWise, and Empower preferred.
Why You Should Join Catalent
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
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 green initiatives including regularly participating in Beach Clean-up.
Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
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.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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