Senior Scientist, Analytical Research & Development

Catalent • Saint Petersburg, FL

1d • Onsite

About The Position

The Senior Scientist, Analytical Research & Development supports analytical test method development and validation, raw material evaluation, and testing of non-commercial materials. The work advances product development, manufacturing, process validation, and new material qualifications in accordance with regulatory and quality standards. The role is based at Catalent’s softgel development and manufacturing facility in St. Petersburg, Florida, and provides exposure to a diverse portfolio of molecules formulated into softgels, with hands-on experience from development through commercial validation in a CDMO environment.

The scientist independently develops, validates, and executes instrumental methods for drug substances and drug products; analyzes and documents results in compliance with cGMP and internal guidelines; and communicates findings in writing and presentations. The position may lead designated projects, communicate directly with clients, collaborate with customers and suppliers, and support new product development. It also performs testing across finished products, in-process materials, raw materials, fill moisture, and cleaning verification or validation samples, and supports new material evaluation.

The role writes and reviews analytical methods, deviations, protocols, specifications, SOPs, and laboratory investigations; uses root cause analysis tools; and leads analytical method transfers as needed. It ensures accurate, right-first-time execution and data integrity, maintains compliant laboratory records, safely handles potent and teratogenic compounds, and supports laboratory supplies and equipment. The scientist contributes to continuous improvement, training, cross-functional teams, and production and validation schedules, including working flexible hours when required.

Requirements

• A doctorate in a scientific field and at least 3 years of laboratory experience, including 2 years in GMP; or a master’s degree in a scientific field and at least 5 years of laboratory experience, including 3 years in GMP; or a bachelor’s degree in a scientific field and 10 years of laboratory experience, including 8 years in GMP.
• At least 5 years of experience with identification or separation techniques such as HPLC, UPLC, GC, MS, or NMR.
• Experience with analytical method development and/or validation.
• Ability to read written documents and computer monitors, differentiate colors, and maintain 20/30 vision with or without corrective lenses.
• Ability to work extended or off-hours as required.
• Ability to sit, stand, and walk regularly and occasionally lift up to 15 pounds; lifting more than 44.09 pounds requires assistance.

Responsibilities

• Independently develop, validate, and routinely execute instrumental test methods for drug substances and drug products.
• Analyze data, document results according to cGMP and internal guidelines, and communicate findings through written and oral presentations.
• Serve as lead scientist for designated projects, communicate directly with clients, participate in project meetings and teleconferences, and support product development with customers and suppliers.
• Analyze finished products, in-process materials, raw materials, fill moisture, and cleaning verification or validation samples.
• Support the Material Evaluation Process for new materials according to assigned specifications, methods, and protocols.
• Write, review, and support analytical methods, deviations, protocols, specifications, SOPs, and laboratory investigations using appropriate root cause analysis tools.
• Lead analytical method transfer activities as required.
• Ensure right-first-time execution of departmental methods and SOPs; audit and verify analytical results for accuracy and data integrity.
• Maintain notebooks, reports, and logbooks in compliance with FDA, EPA, OSHA, and company regulations.
• Safely handle potent and teratogenic compounds; prepare reagents, standards, and media; and manage hazardous waste disposal.
• Support ordering and maintenance of laboratory materials and equipment.
• Train colleagues, lead and coordinate personnel training, participate in inter-departmental teams, interface with management, and self-schedule assignments.
• Work flexible hours as required to support production and validation schedules.
• Perform other duties as assigned.

Benefits

• Tuition reimbursement
• WellHub physical wellness program
• Perkspot discounts from over 900 merchants
• 152 hours of PTO plus 8 paid holidays
• Medical, dental, and vision benefits effective day one
• Defined career path with annual performance reviews and potential for career growth
• Employee Resource Groups and community engagement

What This Job Offers

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