Senior Scientist, Quality Control

Catalent Pharma Solutions • St. Petersburg, FL

1d • Onsite

About The Position

The Senior Scientist, Quality Control performs testing and release of materials and products in accordance with approved methods, specifications, compendial requirements, and regulatory standards. The role conducts microbiological, environmental, utility, and analytical testing while ensuring compliance with cGMP, SOPs, data integrity standards, and regulatory requirements. It also supports method development, validation, technology transfers, and new product qualifications, and provides technical guidance while helping maintain laboratory operations.

The position is based at Catalent’s St. Petersburg, Florida site, a softgel development and manufacturing facility with analytical laboratory services supporting method development, routine QC testing, and commercial and development stability studies. The role is 100% onsite and follows standard Monday-through-Friday hours, with flexible hours including evenings and weekends as needed to support manufacturing and validation schedules.

Requirements

• Bachelor’s degree in Science or a related field required.
• Eight 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.
• Ability to sit, stand, and walk regularly and occasionally lift up to 15 pounds; lifting more than 44.09 pounds requires assistance.
• Must be accessible to manufacturing, laboratory, and office staff and able to use required office equipment.
• Vision requirements include the ability to differentiate colors, have 20/30 vision with or without corrective lenses, read written documents, and frequently use a computer monitor.
• Ability to work extended hours or off-hours as required.

Nice To Haves

• A degree in Chemistry, Microbiology, or Biology is preferred.

Responsibilities

• Perform testing and release of raw materials, in-process materials, intermediates, finished products, validation samples, and non-routine products using 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; 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.
• 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.

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 to promote 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