The Chromatography Development department is part of the Analytical Development and Documentation function within Global Product Management in Integrated Supply Chain (ISC), Pharmaceutical Diagnostics (PDx). The Analytical Development and Documentation function has specialist competence in the analytical techniques GC/GC-MS, HPLC/HPLC-MS, ICP/ICP-MS, NMR, spectroscopy (IR, NIR, UV/VIS), and general analytical chemistry. Candidates with experience in any of these techniques will be considered. In Pharmaceutical Diagnostics (PDx) at GE Healthcare, a large variety of analytical chemistry techniques are used throughout the development phase of new drug products as well as for routine testing of existing products. The analytical scientists will be responsible for development and validation of analytical procedures, perform quality control and stability analysis of materials and products for clinical trials, and provide support to establishment of product specifications, reference standards and to formulation and process development within the projects.
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.
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
Provide scientific support and analysis during development of new chemical processes and new drug products.Development, validation, and documentation of analytical methods according to the GMP regulations. Including writing protocols, reports, and regulatory documents.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.Other relevant responsibilities depending on previous experience and competence.Qualifications/Requirements
BSc or MSc in Analytical Chemistry, preferably with knowledge and hands-on experience of gas chromatography (GC) and/or other chromatography techniques.Fluent in oral and written English.Minimum basic working proficiency in Norwegian.Desired 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.Experience in analytical method development and validation, and good understanding of the regulatory requirements and good manufacturing practice (GMP).Work systematically and rapidly learn new tasks.Analyze data and produce workable solutions to a range of problems.Focus on customer needs and set high standards for quality.Manage time effectively in a high-pressure environment.Work independently and as part of a team.Listen, consult others, and communicate proactively.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.
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Additional InformationRelocation Assistance Provided: No