Scientist, Analytical Ops

Key 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.

Basic Qualifications:

• BSc with at least 8 years of relevant experience

OR

• MSc with at least 6 years of relevant experience

Preferred Qualifications:

• 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, HRMS, 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.