Senior Scientist, Analytical Development & E&L

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 92,000 - 95,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits (medical, dental, and

Vision coverage

Employee assistance program

Job summary

Fresenius Kabi USA in Melrose Park, IL is seeking a Senior Scientist, Analytical Development to lead method development, validation, and analytical testing. You will design extractable/leachable studies and apply MS techniques to solve complex challenges in a cGMP environment.

The role requires strong knowledge of analytical chemistry, mass spectrometry, regulatory expectations (FDA/ISO), and the ability to manage multiple projects while training junior scientists.

Qualifications

• Bachelor’s in Pharmaceutical Sciences, Chemistry, or Biological Sciences with 5+ years' related experience.
• Master’s in the same fields with 3+ years' related experience.
• PhD in Pharmaceutical Sciences, Chemistry or Biological Sciences preferred.
• Strong knowledge of Analytical Chemistry and mass spectrometers.

Responsibilities

• Design and review extractable/leachable study concepts to meet regulatory requirements.
• Lead method development, validation, and analytical testing.
• Interpret MS data and support impurity identification.
• Train junior scientists and manage multiple projects.

Skills

Analytical Chemistry

Mass Spectrometry

Regulatory Compliance

Method Development

Problem Solving

Scientific Writing

Team Training

Education

Bachelor’s degree in Pharmaceutical Sciences or Chemistry or Biological Sciences

Master’s degree in Pharmaceutical Sciences or Chemistry or Biological Sciences

PhD in Pharmaceutical Sciences or Chemistry or Biological Sciences

Tools

Agilent HS-GC/MS

GC-MS

LC-MS

ICP-MS

Job description

Fresenius Kabi USA in Melrose Park, IL is seeking a Senior Scientist, Analytical Development to lead method development, validation, and analytical testing. You will design extractable/leachable studies and apply MS techniques to solve complex challenges in a cGMP environment.

The role requires strong knowledge of analytical chemistry, mass spectrometry, regulatory expectations (FDA/ISO), and the ability to manage multiple projects while training junior scientists.