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
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
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 (<1663> and <1664>), 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.
- Hands-on experience operating, maintaining, and troubleshooting 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.
- Knowledge and experience in mass spectral interpretation and unknown compound identification.
- Prepare E&L studies and safety assessment summaries for regulatory dossiers and address regulatory deficiency responses related to E&L.
- Understanding and effectively communicating the strategic focus/plan to team members.
- Communicate clearly with the manager, peers, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles while seeking input from other team members.
- All employees are responsible for ensuring compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
- Other duties as assigned and business needs.
REQUIREMENTS
- Bachelor’s degree in, Chemistry, Pharmaceutical Sciences Biological Sciences with seven plus years of related experience or a Master’s Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5 years of related experience or a PhD in Chemistry, Pharmaceutical Sciences, Biological Sciences, Chemical/Biomedical Engineering with one to three years of related experience is required. Sufficient knowledge and work experience in extractable and leachable or Mass spectrometry is a plus.
- Have a basic understanding and work experience in various mass spectrometry techniques, such as HS-GC/MS, GC-MS, HRLC/MS, and ICP/MS, to aid in data interpretation of chemical characterization of E&L compounds and unknown compound Identification.
- Prior Extractable and Leachable OR Mass spectrometry OR Trace level impurity analysis work experience in an industry or a CRO environment is a plus.
- Skills in designing and executing experiments, interpreting test results, and solving problems.
- Excellent written and verbal communication skills and should be a good team player.
- Flexible, adaptive, strong desire to work in a dynamic environment, responsive to urgency.
- Self-motivated, empowered personality, result- and deadline-oriented
- Strong organizational skills, attention to detail, interpersonal skills, and ability to manage competing priorities are essential for success.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
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.
