Senior Scientist, Quality Control

Catalent • Saint Petersburg, FL

3d • Onsite

About The Position

The Senior Scientist, Quality Control performs testing and release of materials and products using approved methods and in accordance with specifications, compendial requirements, and regulatory standards. The role conducts microbiological, environmental, utility, and analytical testing while ensuring cGMP compliance and data integrity. It also supports method development, validation, technology transfers, and new product qualifications; interprets and documents results; reviews analytical data; and provides technical guidance and training to laboratory staff.

The position supports laboratory operations and continuous improvement at Catalent’s St. Petersburg, Florida site, a softgel development and manufacturing facility offering formulation, analytical, and manufacturing services. The role is onsite and follows standard hours Monday through Friday, with flexibility to work evenings and weekends when manufacturing or validation schedules require it.

Requirements

• Bachelor’s degree in Science or a related field; Chemistry, Microbiology, or Biology is preferred.
• Eight years of analytical laboratory experience.
• 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; ability to collaborate effectively and maintain organized laboratory records and workflows.
• Ability to work extended hours or off-hours as required.
• Ability to sit, stand, and walk regularly; occasionally lift up to 15 pounds, and not lift more than 44.09 pounds without assistance.
• Ability to be accessible to manufacturing, laboratory, and office staff and use required office equipment.
• Vision ability to differentiate color, have 20/30 vision with or without corrective lenses, read written documents, and frequently use a computer monitor.

Nice To Haves

• Degree in Chemistry, Microbiology, or Biology.
• Experience with selective and non-selective media, Gram staining, and API techniques.

Responsibilities

• Test and release raw materials, in-process materials, intermediates, finished products, validation samples, and non-routine products according to 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, including statistical analyses, and 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.
• Safely handle potent and teratogenic compounds, dispose of hazardous waste properly, and comply with FDA, EPA, OSHA, and internal safety requirements.
• Work flexible hours, including evenings and weekends, as needed to support manufacturing and validation schedules.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Employee Resource Groups focused on diversity and inclusion.
• WellHub program promoting physical and mental wellness.
• Perkspot discounts from approximately 900 or more merchants.
• Defined career path and annual performance review and feedback process, with potential for career growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior