Scientist, Analytical Ops

Responsibilities

• Extractables & Leachables (E&L) Strategy & Execution
• Design and execute extractables and leachables (E&L) studies to support injectable biological drug products, container closure systems, and medical devices .
• Develop and author E&L protocols, reports, and risk assessments in alignment with regulatory expectations.
• Evaluate leachable 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)
• Identify and characterize unknown compounds using spectral libraries and structure elucidation tools.
• Perform trace-level quantification of leachables and extractables in complex matrices.
• Support contract laboratory oversight , including study design review, execution monitoring, and data verification.
• Method Development & Validation
• Develop, optimize , and verify analytical methods for E&L testing across complex pharmaceutical matrices.
• Implement screening strategies for extractables and leachables assessments.
• Utilize appropriate sample preparation techniques, including:
• Solid-phase extraction (SPE)
• Liquid-liquid extraction (LLE)
• Protein precipitation
• Apply semi-quantitative approaches using surrogate standards and justify analytical uncertainty where authentic standards are unavailable.
• Cross-Functional Collaboration
• Collaborate with toxicology teams to assess patient risk and establish Analytical Evaluation Threshold (AET)
• Partner with Device/Packaging, Process Development, and Formulation Development teams to support product lifecycle activities.
• Present findings and recommendations using a data-driven approach to inform technical strategy and decision-making.
• Documentation & Compliance
• Author, review, and approve technical reports and documentation , ensuring scientific accuracy, data integrity, and traceability.
• Ensure compliance with applicable regulatory guidelines and standards (USP, FDA, EMA, ICH, PQRI).
• Stay current with emerging technologies and industry trends and apply advancements to improve analytical capabilities.

Requirements

• BSc with at least 8 years of relevant experience
• OR
• MSc with at least 6 years of relevant experience
• PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 0+ years of experience, Strong expertise in trace-level impurity detection and identification .
• Demonstrated experience with analytical instrumentation (GC-MS, LC- UV /MS, HR MS , ICP-MS).
• Proven experience with sample preparation techniques (SPE, LLE, protein precipitation).
• Strong understanding of structural characterization and compound identification techniques .
• Experience with regulatory submissions and E&L strategy development .
• Track record of scientific publications and conference presentations .
• Excellent analytical thinking, problem-solving, and troubleshooting skills .
• Strong communication and presentation skills , with the ability to influence cross-functional stakeholders.
• Ability to thrive in a collaborative, fast-paced environment .
• For additional benefits

Benefits

Additional Information

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description

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