Ge Healthcare

Oslo

The Analytical Chemistry team, part of Chemistry, Manufacturing and Controls (CMC) Development team within Pharmaceutical Diagnostics (PDx) R&amp;D at GE HealthCare, is responsible for analytical characterization, method development, and supporting documentation for early-phase research and new product introductions (NPIs).
Extractables are chemical compounds that can be ‘extracted’ out from materials like container closure systems and manufacturing process components when they are exposed to harsh or exaggerated operational or storage conditions. Leachables are a subset of these extractables that actually migrate into the drug product under normal storage or use conditions. Because extractables and leachables (E&amp;L) are usually present in very low concentrations compared to drug products and excipients, highly sensitive and specific analytical methods must be developed and validated to detect and quantify them accurately, facilitating an assessment of their risk.
We seek a highly motivated and innovative Analytical Scientist with expertise in gas chromatography (GC) and the analysis of volatile organic compounds (VOCs) to join our team and enhance our expanding Extractables &amp; Leachables (E&amp;L) assessment work. As well as their analytical chemistry experience, the ideal candidate will have prior experience with risk-based assessment approaches and E&amp;L studies. In this role, you will take on a collaborative and coordinating position, supporting risk assessments, gap analyses, and the planning of E&amp;L mitigation strategies across our Contrast Media and Radiopharmaceutical development pipeline, ensuring regulatory compliance. You will also contribute to the evaluation of drug product stability, structural elucidation of unknowns, and interpretation of analytical data.
Roles and Responsibilities
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Support the risk-based Extractables &amp; Leachables (E&amp;L) strategy across various New Product Introduction (NPI) programs, and lead risk assessments, evaluations, gap analyses, and the planning of mitigation activities.
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Collaborate with cross-functional CMC project teams to define and achieve E&amp;L-related objectives and timelines.
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Coordinate E&amp;L activities both internally and with external partners or contract laboratories.
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Author and review scientific protocols and reports to support regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs).
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Maintain up-to-date knowledge of regulatory guidance related to E&amp;L in drug product development.
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Contribute to the implementation of standard work for executing on our internal E&amp;L strategies and best practices.
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Provide expert support for all GC-related activities, including troubleshooting, method development, and protocol reviews.
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Ensure GC data integrity and regulatory compliance by evaluating results, reviewing documentation, and maintaining best practices in GC analysis.
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Required Qualifications
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Ph.D. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or a related field, with relevant experience in the pharmaceutical or medical device industry.
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Strong technical expertise in gas chromatography (GC), including the use of various detectors and sample introduction techniques.
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Solid theoretical and practical understanding of method development and validation in accordance with ICH and other regulatory guidelines.
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Excellent adherence to Good Documentation Practices (GDP).
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Strong communication and interpersonal skills, with the ability to work effectively in cross-functional and multicultural teams.
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Highly motivated, scientifically rigorous, attention to detail and committed to continuous improvement.
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Strong analytical thinking and problem-solving abilities.
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Fluent in English, both written and verbal.
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Desired Characteristics
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Prior experience in Extractables &amp; Leachables (E&amp;L) studies.
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Familiarity with risk-based approaches and regulatory expectations.
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Experience with New Drug Applications (NDA)/CMC filings.
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Fluency in Norwegian or willingness to learn if based in Oslo.
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Ge HealthCare is hiring: Lead Analytical Chemist - Extractables and Leachables