Senior Scientist, Analytical Research & Development

Position Summary

We have an opportunity for a Senior Scientist, Analytical Research & Development to join our team. This role involves developing, validating, and executing test methods for Drug Substances and Drug Products. The position includes analyzing data, documenting results, maintaining laboratory records, and communicating findings through written and oral presentations. The Senior Scientist will also contribute to writing procedures, specifications, and test methods, while supporting continuous improvement and compliance with all regulatory and safety standards.

Shift: Monday - Friday, 8:00am to 5:00pm. Location: St. Petersburg, FL 100% Onsite.

The Role

• Independently develop and validate instrumental methods in support of Drug Substances and Drug Products
• Serve as lead scientist for designated projects, including direct client communications and participation in project meetings and teleconferences
• Analyze finished products, in-process materials, raw materials according to assigned specifications and protocols
• Prepare reagents, standards, and media needed for analysis according to established methods
• Safely handle potent and teratogenic compounds; Dispose of hazardous waste according to environmental regulations and company procedures
• Write and review analytical methods, deviations, protocols, SOPs, and other technical documents; Tabulate and interpret analytical results in notebooks, reports, and logbooks
• Lead analytical method transfer activities as required
• Interfaces with peers in other departments and management
• All other duties as assigned

The Candidate

Minimum Requirements

• Requires Ph.D. in a scientific field with 3 years of laboratory experience and 2 years in Good Manufacturing Practice OR Master of Science in a scientific field with 5+ years of laboratory experience and 3 years in Good Manufacturing Practice OR Bachelor of Science in a scientific field with 10 years of laboratory experience and 8 years in Good Manufacturing Practice
• Minimum of 5 years of experience with identification or separation techniques such as High-Performance Liquid Chromatography, Ultra-Performance Liquid Chromatography, Gas Chromatography, and Mass Spectrometry, including method development and validation
• Experience with drug development and regulatory requirements for submissions; Experience using data acquisition systems such as Chemstation, Empower, and Totalchrom
• Expertise in wet chemistry techniques such as titrations, extractions, digestions, and preparation of test solutions
• Familiarity with International Council for Harmonisation and United States Pharmacopeia/European Pharmacopeia method validation requirements
• 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
• Vision requirements include ability to differentiate color (pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent's in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.

Preferred Skills & Background

Experience in peptides handling and method development is preferred.