Senior Scientist – E&L Method Development

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

Benefits offered by this job

401(k) plan with company contributions

Healthcare (medical, dental, vision)

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Senior Scientist, Analytical Development to advance method development and validation in a cGMP setting. You will conduct MS-based analyses, interpret results, and draft reports for regulatory dossiers, collaborating with cross-functional teams.

The role requires a strong background in Analytical Chemistry and Mass Spectrometry, with 5+ years of related experience (or 3+ with a PhD) and the ability to manage multiple projects and communicate clearly in

Qualifications

• Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry or Biological Sciences with several years of related experience.
• Extensive knowledge of Analytical Chemistry and various Mass spectrometers.
• Experience in extractable/leachable testing and regulatory awareness.

Responsibilities

• Reviews extractable/leachable study design concepts per USP/ISO regional requirements.
• Performs extractable and leachable testing including method development and validation in a cGMP environment.
• Acts as SME in mass spectrometry and E&L.
• Operates GC/MS, HR-LC/MS and other analytical methods in a cGMP setting.
• Evaluates results, identifies trends, and supports product requirements and toxicology assessments.
• Drafts, reviews, and approves E&L testing protocols and reports.
• Performs mass spectral interpretation and unknown compound identification.
• Prepares E&L studies and safety assessments for regulatory dossiers.

Skills

Mass spectrometry

Analytical Chemistry

Method development

cGMP

Regulatory compliance

Data interpretation

Project management

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biological Sciences

Master's degree in Pharmaceutical Sciences, Chemistry, Biological Sciences

PhD in Pharmaceutical Sciences, Chemistry, Biological Sciences

Tools

GC/MS

HR-LC/MS

ICP/MS

Job description

Fresenius Kabi in Melrose Park, IL seeks a Senior Scientist, Analytical Development to advance method development and validation in a cGMP setting. You will conduct MS-based analyses, interpret results, and draft reports for regulatory dossiers, collaborating with cross-functional teams.

The role requires a strong background in Analytical Chemistry and Mass Spectrometry, with 5+ years of related experience (or 3+ with a PhD) and the ability to manage multiple projects and communicate clearly in