Bioanalysis & Biomarker Specialist

The position

As a Specialist, you will develop ligand-binding assays (LBA) in-house as well as ensure outsourcing of our pharmacokinetic (PK) assays and biomarker assays to Contract Research Organisations (CROs). You are expected to spend as much time on outsourcing as on in-house activities. Outsourcing includes identification of suitable CROs, setting up contracts for validation of assays, supporting trial sample analysis, and ensuring transfer and cross-validation of assays from Novo Nordisk to the CROs. Your main responsibilities will include: Designing, executing and concluding on experiments in alignment with project plans and results Conducting scientific research and development within Development Bioanalysis and Biomarkers Participating in projects progression, contributing to the evaluation of relevant targets and engineering therapeutic compounds Collaborating with laboratory technicians, providing relevant information and supporting a well-balanced workload Ensuring scientific quality of studies and general procedures, treating data and results according to Novo Nordisk and regulatory standards Qualifications To be successful in this position, you have: PhD within Biology, Biochemistry or similar field Several years of industry experience within development bioanalysis and/or biomarkers Insight in clinical development from an outsourcing management perspective and knowledge of the regulatory guidelines and the GLP/GCP principles Ideally, proficient in 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 LBA Bioanalysis & Biomarkers consists of two siter 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. 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. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive change. 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. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 60, employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.