Senior Scientist, Quality Control

Senior Scientist, Quality Control Role

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 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 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

The Role

- 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.

The Candidate

Minimum Requirements

- 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 interpersonal, verbal, and written communication skills, with the ability to collaborate effectively with coworkers and maintain organized laboratory records and workflows.
- 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.
- Can use required office equipment.
- Vision requirements include ability to differentiate color, have 20/30 vision with or without corrective lenses, read written documents, and frequent use of a computer monitor.
- Ability to work extended hours or off-hours as required.

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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 regular participation 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 [email protected] . 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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