Senior Scientist, Analytical Research & Development

Catalent Pharma Solutions • St. Petersburg, FL

15h • 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 to advance product development, manufacturing, process validation, and new material qualifications in accordance with regulatory and quality standards. Based at Catalent’s flagship softgel development and manufacturing facility in St. Petersburg, Florida, the role supports a diverse portfolio of products and collaborates across functions in a contract development and manufacturing organization (CDMO) environment.

The scientist independently develops, validates, and executes instrumental test methods for drug substances and drug products; analyzes data; documents results under cGMP and internal guidelines; and communicates findings in writing and presentations. The position may serve as lead scientist on designated projects, including customer communications and collaboration with customers and suppliers. It also involves analysis of finished products, in-process materials, raw materials, fill moisture, and cleaning verification or validation samples, along with support for new-material evaluations.

The role includes writing and reviewing analytical methods, deviations, protocols, specifications, SOPs, and laboratory investigations; applying root cause analysis tools; and leading method transfers when required. The scientist helps ensure accurate, right-first-time execution and data integrity, maintains compliant records, safely handles potent and teratogenic compounds, and supports laboratory supplies and equipment. The position also contributes to continuous improvement, staff training, cross-functional teamwork, and production and validation schedules. Work is Monday through Friday, standard hours, and 100% on-site, with flexible or off-hours work as needed.

Requirements

• Doctorate in a scientific field and 3 years of laboratory experience, including 2 years in GMP; or a master’s degree in a scientific field and 5 or more 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 color, and maintain 20/30 vision with or without corrective lenses.
• 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 work extended or off-hours as required.

Responsibilities

• Independently develop, validate, and routinely execute instrumental test methods for drug substances and drug products.
• Analyze data, document results in accordance with 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; use 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; manage hazardous waste disposal; and support ordering and maintenance of laboratory materials and equipment.
• Train colleagues and lead or coordinate personnel training; participate in interdepartmental teams and interface with management.
• Self-schedule assignments and work flexible hours as required to support production and validation schedules.
• Perform other duties as assigned.

Benefits

• Tuition reimbursement to support educational goals.
• WellHub program to promote physical wellness.
• Access to Perkspot discounts from over 900 merchants.
• 152 hours of paid time off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one.
• Defined career path with annual performance reviews and potential for career growth.
• Inclusive culture with active Employee Resource Groups, community engagement, and green initiatives.

What This Job Offers

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