Fluid Biomarker and Bioanalysis Specialist

Fluid Biomarker and Bioanalysis Specialist – Translational Biomarkers and Imaging Department.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, it has been at the forefront of research within neurosciences and its key areas of focus are neurology and psychiatry.

Lundbeck’s passion links to our purpose about restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative treatments, we improve the lives of people living with brain diseases. Your dedication is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.

The Translational Biomarkers and Imaging Department was launched in 2020 and comprises a group of ten members with different expertise and skills in the field of biofluids and neuroimaging biomarkers. Through cross-functional collaborations with internal and external stakeholders, the main goal of the team is to identify appropriate studies that will demonstrate the mechanism of action of the compound and establish biomarkers to tap into the circuit biology, from the early stages in the pre-clinical portfolio to studies that are clinical trial phases.

Description

We are looking for a highly skilled and experienced specialist in fluid biomarker analysis, to build and oversee assay development and implementation processes for clinical studies aimed at tackling neurodegenerative, psychiatric and neuro-immunological disorders. This includes the identification of specialized CRO’s, the management of study conduct and outsourcing and, importantly, the full understanding of the translational expectations of the biomarker within the specific context of use, in order to define the level of assay validation for decision making. This will be key to communicate the strategy across the stakeholders from different lines of business to enable right and agile decisions.

The position requires a good experience and knowledge of immunoassay technologies such as ELISA, ECLIA, automated analyzer, multiplex assays and single molecule analyzers such as SIMOA. Furthermore, knowledge on mass-spectrometry platforms such as triple quadruple instruments and high-resolution MS will also be valued, as well as chromatographic- based systems.

Location/Travel: Valby, Copenhagen, Denmark. Travel as necessary to collaboration sites, conferences etc.

The job & key responsibilities

Decide on relevant assay validation parameters and acceptance criteria to fit the context of use and collaborate with the CRO to ensure a fit-for-purpose analytical validation of high quality.

Identification of relevant specialized CROs for method validation and analysis for each new fluid biomarker.

Interact closely with internal stake holders to understand the intended context of use, establish the necessary methods to develop the biomarker strategy meeting the required expectations, and assure the good interpretation of the ultimate results.

Provide input to nonclinical and clinical study plans for fluid biomarker sample analyses.

Qualifications

A PhD on analytical chemistry, biochemistry, biotechnology or molecular biology.

Preferably over 10 years of experience in biomarker development and validation.

Deep knowledge on the concepts of fit-for-purpose and context of use.

Previous experience with immunoassay technologies.

Previous experience with LC-MS technologies.

Experience from work in developing clinical diagnostic tests is also desirable

We offer

Lundbeck offers a great workplace that is based on a flat structure, forming a collaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients. The opportunity to join a whole new department within the company, composed by experienced members in the field of neuroimaging, proteomics, genomics, etc. makes this a unique opportunity to build up a strong, innovative Unit that will provide state-of-the-art resources and knowledge to the overall company strategy.

Further information

For further information, please contact Garry Honey gahn@lundbeck.com

Your application and CV should not be sent via email.

We also recommend that you have a look at our website, LinkedIn and Instagram.

Your application

Please click on the apply button. Applications must be received no later than 03 May 2021.