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Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Senior Principal Scientist serves as the Extractables & Leachables (E&L) Subject Matter Expert (SME) within the Material Sciences department of Therapeutics Development and Supply (TDS). Operating with minimal supervision this role leads multi-disciplinary E&L programs spanning several drugdevice combination product portfolios shaping scientific strategy regulatory pathways and external influence. The position collaborates closely with cross-functional teams and external laboratories to design and interpret chemical characterization studies aligned with FDA guidance on chemical analysis for biocompatibility assessment and ISO 10993 standards. The role drives portfolio-level decisions under ambiguity by integrating risk assessments regulatory feedback and business constraints to enable safe effective and compliant therapies. The Senior Principal Scientist E&L SME serves as a key decision-maker and advisor on E&L strategy across programs.

Key Responsibilities

• Own the E&L strategy for assigned programs integrating risk assessments and regulatory feedback into development plans with direct impact on portfolio decisions.
• Represent Material Sciences as the E&L SME in cross-functional governance forums and regulatory interactions.
• Design and review chemical characterization studies for medical devices and drugdevice combination products ensuring scientific rigor and regulatory readiness.
• Interpret LCMS and GCMS related analytical data; author high-quality technical reports and health authority responses.
• Engage proactively with health authorities (e.g. FDA/EMA) to conduct scientifically sound discussions and resolve queries efficiently.
• Lead collaboration with internal teams and contract laboratories to secure timely compliant deliverables and optimize CRO network performance.
• Influence industry standards through active participation in external forums and working groups (e.g. ELSIE PQRI ISO USP ICH) such as draft ICH Q3E.
• Ensure adherence to ISO 10993 and other relevant global standards; implement best practices to reduce cycle time and de-risk submissions.

Qualifications

Required:

• Ph.D. in Chemistry (Analytical preferred) with 6 years relevant experience OR Masters with 8 years OR Bachelors with 10 years.
• Expertise in designing E&L studies for medical devices and drugdevice combination products in accordance with FDA guidance on chemical analysis for biocompatibility assessment and aligned with ISO 10993 standards.
• Demonstrated expertise in conducting exhaustive extraction studies and effectively managing complex data sets derived from these analyses.
• Proven experience in E&L screening and targeted LCMS and GCMS analyses including semi-quantitative approaches utilizing Relative Response Factors (RRF) and Uncertainty Factor (UF) determination.
• High-level competence in ICPMS NVR TOC FTIR and other analytical chemistry techniques relevant to E&L.
• Demonstrated ability to engage with health authorities author well-structured regulatory responses and conduct scientifically sound discussions during formal meetings.
• Track record of leading cross-functional E&L programs from study design through regulatory engagement driving decisions under limited information.
• Strong communication project management skills and the ability to influence cross-functional teams; knowledge of risk assessment concepts and lifecycle management for E&L.

Preferred:

• Demonstrated success in managing partnerships with contract laboratories to ensure timely and compliant deliverables.
• Experience applying mathematical and migration modeling tools in E&L assessments and/or food contact material evaluations.
• Familiarity with Power Query for data analysis and reporting is advantageous.
• Active participation and thought leadership in E&L forums and industry working groups.

Organizational Impact & Complexity

• Works under minimal supervision and leads complex programs/projects spanning multiple related areas.
• Provides subject matter expertise to recommend operational strategies and plans with direct impact on business results.
• Applies comprehensive knowledge to address complex problems requiring innovative solutions.

Travel: Yes up to 10% of the time.

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