Join our mission as our new Lead Analytical Scientist!

The Analytical Chemistry department is scientifically responsible for developing, evaluating, and validating analytical methods, and the related analytical documentation packages for early phase research projects and NPIs within Pharmaceutical Diagnostics (PDx), Research & Development.

The Lead Analytical Scientist will step in as maternity leave cover and have a key role in our team, supporting the continuous development of a contrast media product. Activities include HPLC development and routine analyses activities, as well as supporting chemistry and formulation development. The Scientist will also be expected to work with ICP-OES / ICP-MS analyses techniques and contribute to the GxP housekeeping activities as part of the job.

Responsibilities: 

• To provide analytical expertise in the development, validation, and application of chromatography methods, especially HPLC.
• You will be engaged in hands-on work in the laboratory, but some follow-up of external partners will occur.
• Actively participate in cross-functional project team meetings, report project progress to project leaders and line manager, provide written technical reports as required.
• Produce scientific reports & documentation to support regulatory documentation packages.
• We will look for a person with hands-on experience of additional analytical techniques, and with the ability of multitasking.
• If needed training in ICP-OES and ICP-MS will be provided for analyses work needed in the project.

Qualifications/Requirements:

• MSc or PhD in Analytical Chemistry. Experience with chromatography methods is essential.
• Theoretical and practical knowledge of analytical chemistry method development and validation principles according to ICH and other applicable guidelines (FDA, EMEA, etc).
• Strong documentation skills
• Highly motivated with a passion for rigorous science with a strong drive for continuous improvement.
• Ability to work in a collaborative work environment within a team.
• Having the ability to work in a dynamic, time-sensitive environment and prioritize work as assigned.
• English - fluent verbal and written.

Desired Characteristics/Skills:

• Experience in other analytical techniques, such as: ICP, NMR, GC, Spectroscopy.
• Experience in working under GMP or in an accredited laboratory.
• Comfortable working in a Norwegian language environment.
• Knowledge about the regulatory requirements for analytical methods across the drug development pipeline.
• Familiarity and working knowledge in applying quality by design (QbD) and design of experiments (DoE) principles.