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 Requirements 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 Core Competencies 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 Expertise Extractable And Leachable Testing Analytical Method Development Regulatory Compliance Knowledge Project Management Skills ATS Optimization Keywords Hard 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 Soft Skills Excellent Communication Skills Interpersonal Skills Organizational Skills Attention To Detail Flexibility And Adaptability Industry Keywords USP ISO 10993 FDA Regulations

21 CFR

Pharmaceutical Sciences Tools & Technologies GC/MS

HR-

LC/MS

Agilent HS-GC/MS LC/MS

ICP/MS

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