Lead Scientist, Analytical R&D & Validation

Catalent Pharma Solutions; Saint Petersburg (FL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Tuition reimbursement

WellHub program

PTO 152 hours + 8 holidays

Health benefits from day one

Career development path

Inclusive culture and ERGs

Job summary

Catalent in Saint Petersburg, FL, seeks a Senior Scientist in Analytical Research & Development. The role focuses on developing and validating analytical methods for drugs across the development pipeline, with direct client interactions and cross-functional collaboration in a CDMO setting.

You will drive method transfer, ensure data integrity, and support validation activities while working on a diverse portfolio of molecules for softgel products.

Qualifications

• Doctorate in a scientific field with 3+ years in lab and GMP experience.
• Master's degree with 5+ years lab and 3+ years GMP experience.
• Bachelor's degree with 10+ years lab and 8+ GMP experience.
• Minimum 5 years experience with identification or separation techniques (HPLC, UPLC, GC, MS, NMR) and method development/validation.
• VISION: read documents, differentiate color, 20/30 vision; able to work extended hours.

Responsibilities

• Develop, validate, and routinely execute instrumental test methods for Drug Substances/Products and analyze data per cGMP.
• Lead designated projects, including client communications and cross-functional collaboration.
• Analyze finished products, in-process materials, and raw materials per specifications and protocols.
• Write, review, and support methods, deviations, SOPs, and investigations; lead method transfer activities.
• Audit results for accuracy, data integrity; maintain records in notebooks and logs per regulations.
• Safely handle potent/teratogenic compounds; prepare reagents and manage waste disposal.
• Contribute to continuous improvement by training colleagues and coordinating team activities.
• Other duties as assigned.

Skills

HPLC

UPLC

GC

MS

NMR

GMP

Method development

Project leadership

Education

Doctorate in scientific field

Master's in scientific field

Bachelor's in scientific field

Job description

Catalent in Saint Petersburg, FL, seeks a Senior Scientist in Analytical Research & Development. The role focuses on developing and validating analytical methods for drugs across the development pipeline, with direct client interactions and cross-functional collaboration in a CDMO setting.

You will drive method transfer, ensure data integrity, and support validation activities while working on a diverse portfolio of molecules for softgel products.