Lead Extractables & Leachables Scientist

RXinsider LTD.; Melrose Park (IL); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401K with company contributions

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks an experienced E&L leader to manage the Extractables & Leachables team, guiding study execution and regulatory support. You will oversee the full lifecycle from study design to data generation for regulatory submissions.

Responsibilities include mentoring the team, ensuring compliant study execution, collaborating with analytical and formulation groups, and developing into a recognized subject matter expert as the program evolves.

Qualifications

• Bachelor’s degree with extensive experience in extractables/leachables or MS.
• Strong mass spectrometry knowledge and data interpretation skills.
• Experience aligning E&L programs with regulatory expectations across global agencies.

Responsibilities

• Lead and mentor the E&L team, providing technical direction and prioritizing workstreams.
• Oversee end-to-end E&L program design, execution, reporting and regulatory submissions.
• Collaborate with analytical, formulation and development teams to align strategies.
• Prepare E&L studies and regulatory documentation; respond to FDA queries with solid data.

Skills

Leadership

Regulatory knowledge

Mass spectrometry

Communication

Problem solving

Education

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

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

PhD in Chemistry/Pharmaceutical Sciences/Biological Sciences/Chemical/Biomedical Engineering

Tools

GC/MS

HR-LC/MS

ICP-MS

Soxhlet extraction

Accelerated Solvent Extraction (ASE)

Job description

Fresenius Kabi in Melrose Park, IL seeks an experienced E&L leader to manage the Extractables & Leachables team, guiding study execution and regulatory support. You will oversee the full lifecycle from study design to data generation for regulatory submissions.

Responsibilities include mentoring the team, ensuring compliant study execution, collaborating with analytical and formulation groups, and developing into a recognized subject matter expert as the program evolves.