Job Description Summary

　　The Senior Scientist will have the primary focus in strengthening our Extractables and Leachables (E&L) competence in the Analytical Chemistry group. The Analytical Chemistry department is scientifically responsible for identifying, evaluating, developing, and validating analytical methods, and the related analytical documentation packages for early phase research projects and NPIs within PDx. To join our team, we are looking for a highly motivated and creative senior scientist who enjoys spending time in the lab, while also helping in shaping the overall future E&L strategy.

　　Job Description

　　The Analytical Chemistry team, a department within CMC Development is part of Pharmaceutical Diagnostics (PDx) R&D, GE HealthCare. The Analytical Chemistry department is scientifically responsible for identifying, evaluating, developing, and validating analytical methods, and the related analytical documentation packages for early phase research projects and NPIs within PDx. Key business areas are neurology, oncology, and cardiology, where GE HealthCare provides contrast agents and molecular imaging products across the imaging modalities MRI, X-Ray, Ultrasound, SPECT and PET.

　　To join our team, we are looking for a highly motivated and creative senior scientist who enjoys spending time in the lab, while also helping in shaping the overall future E&L strategy. The ideal candidate will have extensive experience designing and executing E&L studies. This exciting opportunity will have the successful candidate designing and consulting on E&L strategies across our Contrast Media and Radiopharmaceutical development projects pipeline. However, the position also may support examination of Drug product stability profiles, structural elucidation, and data interpretation from related analytical studies as a secondary function.

　　Essential Responsibilities

　　Leads the experimental design, data evaluation, data trending, scientific writing and coordination of E&L studies

　　Subject matter expert (SME) in common analytical chemistry techniques for E&L (HPLC-UV, LC-MS, GC-MS etc.)

　　Identifies, evaluates, develops, and validates analytical methods for extractable and leachable components, suitable for the regulatory submission readiness of NPIs

　　You will be engaged in hands-on work in sample preparation and operation of MS instrumentation, interpretation, analysis, documentation and the reporting of results.

　　Utilizing the latest state of the art MS capabilities/techniques, analytical software and databases to identify and quantify chemical species e.g. leachables, extractables, degradation/reaction products, additives, etc

　　Produce and review suitable scientific reports & documentation to support regulatory documentation packages (IND's, IMPD’s, NDA, MAA, etc).

　　Collaborates with project teams to meet project objectives and timelines

　　Coordination of activities at external partners.

　　Develops and maintains a comprehensive understanding of E&L regulatory guidance during drug product development.

　　Qualifications/Requirements

　　Ph.D. or MSc in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with 5+ years of relevant pharmaceutical/medical devices industry experience or related

　　Theoretical and practical knowledge of method development and validation principles to ICH and other applicable guidelines

　　Outstanding Good Documentation Practices (GDP)

　　Comfortable in working in a GMP environment.

　　Strong background in HPLC/UPLC, LC-MS, GC-MS, E&L testing, and structure elucidation

　　Highly motivated with a passion for rigorous science with a strong drive for Continuous Improvement

　　Good communication and interpersonal skills to fit into a multicultural environment.

　　Have the ability to work in a dynamic, time-sensitive environment and prioritize work as assigned

　　Strong analytical and problem-solving skills

　　English - fluent verbal and written.

　　Desired Characteristics/Skills

　　Familiarity and working knowledge with design aspects in applying QbD and DoE principles.

　　Experience with intact protein analysis and protein fragmentation methods is an added benefit

　　NDA/CMC filing experience

　　Fluent in Norwegian or the willingness to learn.

　　GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

　　Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

　　We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

　　GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or, age, disability, protected veteran status or other characteristics protected by law.

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　　Additional Job Description

　　Additional Information

　　Compensation Grade

　　LPB1

　　Relocation Assistance Provided: Yes