Principal Scientist

Job Summary Provide leadership and direction to the Extractables & Leachables (E&L) team, managing study execution and associated processes to ensure efficient and compliant program delivery. Oversee the full lifecycle of E&L activities, including study design, protocol development, and execution, ensuring high‑quality data generation to support regulatory submissions, including FDA applications. Conduct thorough technical evaluations and approve study reports, risk assessments, and documentation to ensure scientific integrity and compliance. Collaborate closely with analytical and formulation teams to align E&L strategies with product development goals and timelines. Serve as the primary owner of E&L activities, with the expectation to grow into a subject‑matter expert and provide strategic scientific guidance as the program evolves. Salary Range: $80,000-95,000 Responsibilities Lead and mentor the Extractables & Leachables (E&L) team, providing technical direction, prioritizing workstreams, and ensuring effective execution of study activities. Oversee the end‑to‑end E&L program, ensuring studies are designed, conducted, and reported in a timely, compliant, and scientifically sound manner to support product development and regulatory submissions. Collaborate cross‑functionally with analytical, formulation, and development teams to align E&L strategies with overall product and regulatory objectives. Serve as the primary point of accountability for E&L activities, with the expectation to develop into a recognized subject‑matter expert and provide strategic guidance as the program evolves. Demonstrate deep knowledge and experience in regulatory expectations for Extractables & Leachables (E&L), including ISO, USP and , EP, JP, ICH Q3E Guideline for Extractables and Leachables and applicable 21 CFR requirements, and review study design concepts to ensure alignment with global regulatory standards. Perform Extractable and Leachable testing in the lab, which includes method development, method validation, and stability testing in a cGMP environment. Prepare and review regulatory affairs (RA) documentation for Extractables & Leachables (E&L) studies, ensuring alignment with global regulatory requirements, and effectively respond to FDA queries with clear, scientifically sound justifications supported by robust data and technical expertise. Operate, maintain, and troubleshoot GC/MS, HR‑LC/MS, ICP-MS, refluxing, Soxhlet extraction, and Accelerated Solvent Extraction (ASE) and related analytical techniques for Extractables & Leachables testing in a cGMP‑compliant environment. Evaluate analytical results and identify trends/exceptions/interpretations of results relative to chemical characterization, product requirements, and toxicological assessment. Draft, review, and approve E&L analytical testing protocols and reports. Identify and interpret mass spectral data and unknown compounds. Prepare E&L studies and safety assessment summaries for regulatory dossiers and address regulatory deficiency responses related to E&L. Communicate the strategic focus/plan to team members and stakeholders, sharing project status and hurdles while seeking input from other team members. Maintain compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems. Requirements Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biological Sciences with seven plus years of related experience; or Master’s degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5 years of related experience; or PhD in Chemistry, Pharmaceutical Sciences, Biological Sciences, Chemical/Biomedical Engineering with 1 to 3 years of related experience. Sufficient knowledge and work experience in extractables and leachables or mass spectrometry. Basic understanding and work experience in HS‑GC/MS, GC‑MS, HR‑LC/MS, and ICP/MS techniques for data interpretation of chemical characterization of E&L compounds and unknown compound identification. Prior experience in Extractable and Leachable or mass spectrometry or trace level impurity analysis in an industry or CRO environment. Skills in designing and executing experiments, interpreting test results, and solving problems. Excellent written and verbal communication skills and a strong team‑player attitude. Flexible, adaptive, and result‑and deadline‑oriented with strong organizational skills and attention to detail. Interpersonal skills and ability to manage competing priorities. Benefits 401(k) plan with company contributions Paid vacation, holiday and personal days Employee assistance program Health benefits: medical, prescription drug, dental and vision coverage Life insurance Disability coverage Wellness program Equal Opportunity Statement Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. #J-18808-Ljbffr