LCMS Bioanalysis & Biomarker Specialist (Denmark, Måløv)

Jobbeskrivelse
Placering
Måløv, Denmark

Jobkategori
Research

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Are you a highly motivated LCMS bioanalysis scientist with experience in both LCMS assay development and outsourcing? Would you be excited to work across projects in both non-clinical and clinical phases? Then this might be the job for you, apply now for a life-changing career!

The position
As an LCMS Bioanalysis & Biomarker Specialist, you will coordinate development and validation of bioanalytical LCMS pharmacokinetic (PK) and biomarker assays. All work will be outsourced to Contract Research Organisations (CROs). Outsourcing includes identification of suitable CROs, setting up contracts for the method establishment, method validation, supporting non-clinical study and clinical trial sample analysis, and ensuring the efficient transfer and cross-validation of assays from Novo Nordisk to the CROs (or between different CROs).

As an LCMS Bioanalysis & Biomarker Specialist, you will:

• Design, execute and conclude on experiments at the CRO in alignment with project plans and results.
• Conduct scientific research and development within Development Bioanalysis and Biomarkers.
• Collaborate with stakeholders, providing relevant information and supporting a well-balanced workload.
• Ensure scientific quality of studies and general procedures, for data and results according to Novo Nordisk and regulatory standards.
• Set up contracts for validation of assays and support non-clinical study and clinical trial sample analysis.
• Ensure transfer and cross-validation of assays from Novo Nordisk to CROs or between different CROs.
• Analyze and review reports of data, perform advisory functions, and communicate evaluations and implications of bioanalytical data.
• Prepare and review non-clinical and clinical bioanalytical sections of regulatory submissions.
• Participate in process improving self-organizing groups.

Qualifications
To be successful in this position, you have:

• PhD and several years of experience within life science or similar.
• Several years of industry experience within development LCMS PK and biomarker assays.
• Insight in non-clinical and clinical development from an outsourcing management perspective and knowledge of the regulatory guidelines and the GLP/GCP principles.
• Ideally, proficient in LCMS assay development techniques and methodologies.
• Preferably, a flair for digitalisation, automation, AI or Machine Learning.

On a personal level, you have strong communication skills to convey complex scientific concepts, and the ability to collaborate with cross-functional teams to drive scientific research and development initiatives. Additionally, you have a strong quality mindset, are flexible, and ambitious.

About the department
The area LCMS Bioanalysis area consists of two sister departments with 27 highly skilled scientist and laboratory technicians. Our area is part of Non-clinical and Clinical Assay Sciences (NCAS) in Global Drug Discovery in R&ED. NCAS is responsible for non-clinical and clinical bioanalysis of pharmaceutical drugs, covering pharmacokinetic, immunogenicity and biomarker analyses. We support the entire drug product portfolio of Novo Nordisk A/S. We develop and validate assays and run studies in-house and are also responsible for the technical and scientific interpretations when studies are outsourced during late-stage phases. All work is carried out according to relevant white papers and regulatory guidelines.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

NCAS consists of seven departments divided into 4 overall areas: LCMS Bioanalysis, Immunogenicity assessment, LBA Bioanalysis & Biomarkers, and Digital Solutions for Regulated Assays. We have a strong collaborative atmosphere and shared laboratory facilities that house a range of different state-of-the-art techniques, e.g., different ligand-binding assays such as ELISA, MSD, AlphaLISA, RIA, Gyros, SPR, LCMS as well as cell-based assays. NCAS is a GLP/GCP regulated area and is currently undergoing a transformation towards a more digitized and automated laboratory across all departments. Our area is part of the research organisation, and we are situated in Måløv, Denmark.

Contact
For further information, please contact Sune Sporring, Department Manager +45 30794905.

Deadline
5 January 2025.

Please note that we will only conduct interviews after the application deadline has passed.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.