264,000! That is the number of samples managed by the Global Bioanalytics team in 2018. Do you want to join a team recognized in 2018 with a Novartis Institutes for BioMedical Research Team Award for their support of a critical FDA registration? Are you looking to build and grow your leadership opportunities? As a Senior Investigator in the Translational Medicine PK Sciences Bioanalytical group, you will have the opportunity to make a difference. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply.
In the Senior Investigator role, you will lead a local group of ca. 6-8 scientists and apply your scientific expertise to the bioanalysis of biotherapeutics, including proteins, antibody drug conjugates, and nucleic acids. You will manage an elite team of scientists involved in the development and qualification of large molecule assays for pharmacokinetic, pharmacodynamic and immunogenicity supporting all phases of the drug discovery pipeline. Additionally, you will contribute to Immunogenicity risk evaluation, integrating in-silico, cellular and mass spectrometric tools for first-in-human clinical study risk evaluation for Biologics.
In setting the standard for conducting innovative research and helping deliver breakthrough therapies to our patients:
Your main responsibilities will include but are not limited to:
• Managing the daily operations of a local team of associates responsible for the development and qualification of bioanalytical assays for PK, TK, PD and ADA as well as supporting other new modalities such as oligonucleotides and Cell and Gene therapies platforms. • Coordinating project support and planning of lab resources and ensuring high quality data delivery within timelines in support of Global BA teams and other stakeholders. • Providing consultation and technical support for preclinical and clinical Immunogenicity strategy discussions within Global BA and providing data interpretation consistent with current industry and health authority expectations. • Contributing relevant bioanalytical sections to regulatory and submission document (e.g. IB, CTD.) as needed.
What you bring to the role:
• M.S or Ph.D. with substantial and relevant experience in a pharmaceutical, CRO or related industry • Previous hands-on experience with the development of ligand binding assays as well as some experience with qPCR techniques and cellular assays preferred (ex. Flow Cytometry assays, Receptor occupancy assays, Cellular Immunogenicity assays). • Fundamental understanding of immunogenicity assay development and qualification. Ability to assist with LBA method troubleshooting across a variety of platforms. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data. • Evidence of increasing levels of responsibility managing the day-to-day activities of a small group of scientists. • Strong interpersonal communication skills and ability to manage in a dynamic, ever-changing working environment.
WHY CONSIDER NOVARTIS? 750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.