Senior Scientist, Extractable & Leachable

• 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

• 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

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.

• Mass Spectrometry Expertise
• Extractable And Leachable Testing
• Analytical Method Development
• Regulatory Compliance Knowledge
• Project Management Skills

• Analytical Chemistry
• Method Validation
• Mass Spectral Interpretation
• Chemical Characterization
• E&L Testing Protocols
• Troubleshooting GC/MS
• Stability Testing
• Unknown Compound Identification
• CGMP Laboratory Practices
• Regulatory Dossier Preparation

• Excellent Communication Skills
• Interpersonal Skills
• Organizational Skills
• Attention To Detail
• Flexibility And Adaptability

• USP
• ISO 10993
• FDA Regulations
• 21 CFR
• Pharmaceutical Sciences

• GC/MS
• HR-LC/MS
• Agilent HS-GC/MS
• LC/MS
• ICP/MS