Analytical Development Scientist – Method Validation

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 70,000 - 75,000; Full time

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a Scientist, Analytical Development to lead method development, experimentation, and record keeping. The role focuses on developing and implementing robust analytical methods to meet project needs and ensure reliable laboratory performance.

The position requires a BS in Chemistry or related field with 3+ years of experience, strong chromatography skills, and knowledge of GMP/FDA regulations.

Qualifications

• BS degree in Chemistry or related field with 3+ years of experience.
• Experience with chromatography techniques (HPLC, GC, TLC, IC).
• Experience designing and executing experiments using lab instruments.
• Knowledge of statistical analysis and pharmaceutical dosage forms.
• Familiarity with FDA and GMP regulations.
• Strong written and verbal communication skills.

Responsibilities

• Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing.
• Performs validations or verifications of methods including transfer of methods to other testing laboratories.
• Review and approve validation protocol/report, data packages, SOPs and other laboratory documentation.
• Manage stability program by execution of stability testing protocols and providing updates to Regulatory Affairs.
• Support Laboratory operation for instrument qualification.
• Ensure all technologies needed are available for project completion.
• Plan, develop, and implement scientifically designed experimental programs for method development and testing.
• Identify problem areas and propose alternatives and priorities to resolve problems.
• Accurately record experimental procedures, results, and observations to meet GMP requirements.

Skills

Chromatography techniques

Statistical analysis

Problem-solving

Strong communication

English proficiency

Education

Bachelor's degree in Chemistry or related field

3+ years related experience

Tools

HPLC

GC

TLC

IC

FTIR

Karl Fischer

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a Scientist, Analytical Development to lead method development, experimentation, and record keeping. The role focuses on developing and implementing robust analytical methods to meet project needs and ensure reliable laboratory performance.

The position requires a BS in Chemistry or related field with 3+ years of experience, strong chromatography skills, and knowledge of GMP/FDA regulations.