Key Responsibilities:
Extractables &Leachables(E&L) Strategy & Execution
- Design and executeextractables and leachables(E&L) studies to supportinjectable biological drug products, container closure systems, and medical devices.
- Develop and authorE &L protocols, reports, and risk assessments in alignment with regulatory expectations.
- Evaluateleachable profiles across stability studies , identifying trends and potential risks.
Analytical Testing & Characterization
- Conduct and/or oversee analytical testing using advanced instrumentation, including:
- GC-MS, Headspace and Direct Inject
- LC-UV/MS, LC-MS/MS
- High-Resolution Mass Spectrometry (HRMS)
- ICP-MS (elemental impurities)
- Identifyand characterizeunknown compounds using spectral libraries and structure elucidation tools.
- Performtrace-level quantification ofleachablesand extractables in complex matrices.
- Supportcontract laboratory oversight , including study design review, execution monitoring, and data verification.
Method Development & Validation
- Develop,optimize, and verifyanalytical methods for E&L testing across complex pharmaceutical matrices.
- Implementscreening strategies for extractables andleachablesassessments.
- Utilizeappropriate samplepreparation techniques, including:
- Solid-phase extraction (SPE)
- Liquid-liquid extraction (LLE)
- Protein precipitation
- Applysemi-quantitative approaches using surrogate standards and justify analytical uncertainty where authentic standards are unavailable.
Cross-Functional Collaboration
- Collaborate withtoxicology teams to assess patient risk andestablishAnalytical Evaluation Threshold (AET)
- Partner withDevice/Packaging, Process Development, and Formulation Development teams to support product lifecycle activities.
- Present findings and recommendations using adata-driven approach to inform technical strategy and decision-making.
Documentation & Compliance
- Author, review, and approvetechnical reports and documentation , ensuring scientific accuracy, data integrity, and traceability.
- Ensure compliance with applicableregulatory guidelines and standards (USP, FDA, EMA, ICH, PQRI).
- Stay current withemerging technologies and industry trends and apply advancements to improve analytical capabilities.
Basic Qualifications:
BSc with at least8 years of relevant experience
OR
MSc with at least6 years of relevant experience
Preferred Qualifications:
PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field with0+ years ofexperience, Strongexpertiseintrace-level impurity detection and identification.
- Demonstrated experience withanalytical instrumentation (GC-MS, LC-UV/MS,HRMS, ICP-MS).
- Proven experience withsample preparation techniques (SPE, LLE, protein precipitation).
- Strong understanding ofstructural characterization and compound identification techniques.
- Experience withregulatory submissions and E &L strategy development.
- Track recordofscientific publications and conference presentations.
- Excellentanalytical thinking, problem-solving, and troubleshooting skills.
- Strongcommunication and presentation skills, with the ability to influence cross-functional stakeholders.
- Ability to thrive in acollaborative, fast-paced environment.
