The Chromatography Development department consists of 9 experienced HPLC and GC scientists. The primary objective of the Chromatography Development department is to develop and validate chromatography methods for new diagnostic imaging products and substances, support life cycle management of current product portfolio, technology transfer of methods and general support to all PDx sites. The GC Lead Scientist will participate in and independently perform all activities in the GC laboratory and will be scientifically responsible for establishing analytical methods, validation protocols/reports, and scientific studies in accordance with GMP and applicable regulatory guidelines.
GE HealthCare Pharmaceutical Diagnostics (PDx) provides contrast agents and molecular imaging products across the imaging modalities X-Ray, MRI, Ultrasound, SPECT and PET. Key care areas are neurology, oncology, and cardiology.Job Description
Essential Responsibilities
Development, validation, and documentation of analytical methods according to the GMP regulations. Including writing protocols, reports, and regulatory documents.Provide scientific support and analysis during development of new chemical processes and new drug products with special emphasis on GC and GC-MS.Perform routine testing of drug product, drug substance, starting materials and reference standards for the products in development.Contribute to characterization and documentation of starting materials, intermediates, drug substances and reference standards.Preventive maintenance and GMP compliance of the GC instruments, including writing/updating procedures.Provide scientific support to colleagues working in the GC-lab and to our manufacturing plants and QC laboratories.Other relevant responsibilities depending on previous experience and competence.Qualifications/Requirements
MSc or PhD in Analytical Chemistry/Biochemistry or similar qualifications, with in-depth knowledge and hands on experience of using gas chromatography techniques (GC and GC-MS). Additional experience with other chromatography techniques is beneficial.Strong experience in analytical method development and validation, and good understanding of the regulatory requirements.Experienced with current Good Manufacturing Practice requirements.Strong English communication skills and basic working proficiency in NorwegianWork systematically and rapidly learn new tasksAnalyze data and produce workable solutions to a range of problems and demonstrate problem-solving skills.Focus on customer needs and set high standards for qualityManage time effectively in a high-pressure environmentWork independently and as part of a team Listen, consult others and communicate proactivelyDesired Characteristics/Skills
Experience with any of the other analytical techniques available in our laboratory.Experience from working in a GMP or accredited laboratory. Experience with product development and/or QC of pharmaceutical products.Inclusion and DiversityGE 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 expression, age, disability, protected veteran status or other characteristics protected by law.
BehavioursWe 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.
Total RewardsOur 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.
Additional InformationRelocation Assistance Provided: No