JOB DESCRIPTION SUMMARY

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 all analytical characterization and method development work while, also supporting the related analytical documentation packages for early phase research projects and NPIs.

JOB DESCRIPTION

Extractables are compounds that can be extracted amongst others from the container closure systems used in drug products, while leachables are those extractables that has leached / migrated in your drug product. Due to the low concentrations of extractables and leachables (E&L), sensitive and dedicated analytical methods are necessary to be developed and validated.
To join our team, we are looking for a highly motivated and creative analytical scientist who wants to take the next step in their career, by developing in the field of E&L. The ideal candidate will have had some previous experience in the field of E&L studies. The E&L scientist will step into a coordination role and consult, design, plan and execute E&L studies across our Contrast Media and Radiopharmaceutical development projects pipeline, ensuring regulatory compliance. The position will also support the examination of drug product stability profiles, structural elucidation of unknowns, and data interpretation from related analytical studies.

QUALIFICATIONS/REQUIREMENTS

• Ph.D. or MSc in analytical chemistry, pharmaceutical sciences, chemical engineering, bioengineering or related field with 3+ 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)
• Strong technical competence in analytical techniques such as HPLC/UPLC, LC-MS, GC-MS.
• Good communication and interpersonal skills to function across different project teams as well as to fit into a multicultural environment.
• Highly motivated with a passion for rigorous science with a strong drive for Continuous Improvement
• Strong analytical and problem-solving skills
• English - fluent verbal and written.

DESIRED CHARACTERISTICS/SKILLS

• Previous E&L experience.
• Familiarity and working knowledge with design aspects in applying quality by design (QbD) and design of experiments (DoE) principles.
• NDA/CMC filing experience.
• Fluent in Norwegian or the willingness to learn if based in Oslo.
  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.
  

  LI-Onsite

• Lead the experimental design, coordination, evaluation, and scientific writing of E&L studies.
• Collaborates across different CMC project teams to set and meet project E&L objectives and timelines.
• Initiate and coordinate E&L activities at external partners.
• Produce and review suitable scientific reports & documentation to support regulatory documentation sections within submissions (IND’s, IMPD’s, NDA, MAA, etc).
• Develops and maintains a comprehensive understanding of E&L regulatory guidance during drug product development.
• Contribute to the shaping of the continuously developing E&L internal strategy.