Senior Scientist, Extractable & Leachable

Fresenius Kabi USA

Senior Scientist evaluating extractables and leachables for Fresenius Kabi’s injectable medicines and FDA submissions. Operating mass spectrometry methods, validating analyses, interpreting compounds, and preparing regulatory dossier content.

Posted 8/5/2026full-timeMelrose Park • Illinois • 🇺🇸 United StatesSenior💰 $90,000 - $100,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in analytical chemistry and mass spectrometry, with a strong focus on extractable and leachable studies, method development, and regulatory compliance. Proven ability to lead projects, train junior scientists, and communicate effectively across technical and non-technical teams.

Highest-signal resume keywords

Mass Spectrometry ExpertiseExtractable And Leachable TestingAnalytical Method DevelopmentRegulatory Compliance KnowledgeProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical ChemistryMethod ValidationMass Spectral InterpretationChemical CharacterizationE&L Testing ProtocolsTroubleshooting GC/MSStability TestingUnknown Compound IdentificationCGMP Laboratory PracticesRegulatory Dossier Preparation

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsAttention To DetailFlexibility And Adaptability

Tools & Technologies

GC/MSHR-LC/MSAgilent HS-GC/MSLC/MSICP/MS

Industry Keywords

USPISO 10993FDA Regulations21 CFRPharmaceutical Sciences

About the role

Key responsibilities & impact

Evaluate extractable and leachable study designs to meet regional requirements, including USP and ISO 10993
Perform extractable and leachable testing in a cGMP laboratory environment
Conduct method development, method validation, and stability testing
Serve as a subject matter expert in mass spectrometry and extractable/leachable studies
Operate and troubleshoot GC/MS, HR-LC/MS, and other analytical methods
Evaluate analytical results and identify trends, exceptions, and interpretations related to chemical characterization, product requirements, and toxicological assessment
Draft, review, and approve E&L analytical testing protocols and reports
Perform mass spectral interpretation and unknown compound identification
Prepare E&L studies and safety assessment summaries for regulatory dossiers
Communicate strategic focus and project plans to team members
Communicate project status and hurdles with managers, peers, cross-functional teammates, and non-technical audiences
Provide technical training to other scientists and train junior scientists
Lead E&L project activities and manage project milestones
Write, review, and approve analytical methods, validation protocols and reports, E&L testing reports, SOPs, technical memos, investigation reports, change controls, and regulatory dossier content

Requirements

What you’ll need

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or Biological Sciences with 5+ years of related experience, or a master’s degree in these fields with 3+ years of related experience, or a PhD in a listed scientific or engineering field with 1–3 years of related experience
In-depth knowledge of analytical chemistry or pharmaceutical science
Knowledge of various mass spectrometers
Ability to apply chemistry knowledge to method development, method validation, and analytical testing
Hands-on experience with mass spectrometric operations, troubleshooting, and reporting tools
Experience with at least one Agilent HS-GC/MS, GC-MS, LC/MS, or ICP/MS instrument is highly preferable
Knowledge of mass spectral interpretation and unknown compound identification
Understanding of FDA and other regulatory expectations for extractables and leachables, including relevant ISO, USP, EP, JP, 21 CFR sections, and industry standards is preferable
Ability to manage multiple projects and scientific initiatives independently and collaboratively
Ability to execute E&L projects accurately and meet milestones on time
Ability to lead E&L project activities with minimal guidance and supervision
Ability to train junior scientists
Ability to write, review, and approve analytical methods, validation protocols and reports, E&L testing reports, SOPs, technical memos, investigation reports, change controls, and regulatory dossier content
Excellent written and verbal communication skills
Flexibility and adaptability in a dynamic environment
Self-motivated, empowered, results-oriented, and deadline-oriented
Strong organizational, attention-to-detail, interpersonal, and prioritization skills
Willingness to perform testing involving potent, cytotoxic, and/or controlled substances while following required safety procedures
Must be able to effectively speak, read, write, and understand English
Must be authorized to work for any employer in the United States; Fresenius Kabi will not sponsor or take over sponsorship of an employment visa

Benefits

Comp & perks

401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Medical coverage
Prescription drug coverage
Dental coverage
Vision coverage
Life insurance
Disability coverage
Wellness program
Excellent salary and benefits package