5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to positively impact society by speeding delivery of novel therapies to needy patients, then look no further, NIBR is the place to be. As a Bioanalytical Scientific Monitor in the Translational Medicine PK Sciences Bioanalytical group, you will have the opportunity to make a difference. Bring your collaborative nature, commitment to teamwork and relentless focus on improving patient care to us. We are looking for professionals with expertise in clinical bioanalytics of biologics who want to work with the latest therapeutic modalities: gene therapies, cell therapies, bi-trispecific/ScFV antibodies, oligonucleotides/ siRNA, proteins and peptides. The role is within NIBR in East Hanover, NJ or Basel, Switzerland. If you have a collaborative nature, a commitment to teamwork and a relentless focus on improving patient care we want you to apply.
As a Bioanalytical Scientific Monitor in NIBR Translational Medicine’s PK Sciences Bioanalytical group, you will have overall responsibility for overseeing method development, validation, and implementation of immunogenicity and pharmacokinetic assays at CROs as primary endpoints, and/or for safety assays for biologics development, clinical studies and post-marketing studies. Your main responsibilities include but are not limited to: •Conduct bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelines •Manage and monitor bioanalytical activities outsourced to external partners. Act as the interface with clinical teams / stakeholders. Development and qualification of bioanalytical assays at CROs for PK, TK, PD and ADA as well as supporting other new modalities such as oligonucleotides and cell and gene therapies. •Collaborate with the Novartis Informatics group on developing and implementing in-house software solutions for monitoring outsourced studies •Contribute to immunogenicity risk evaluation, applying in-silico, cellular and mass spectrometric tools for first-in-human clinical study risk evaluation for biologics •Lead Immunogenicity data interpretation within study teams and provide consultation and technical support for preclinical and clinical immunogenicity strategy discussions within Global BA. •Contribute to relevant bioanalytical sections of regulatory and submission documents (e.g. IB, CTD.) as needed Additionally, you will contribute to the strategic direction and leadership for staff, build strong teams, attract and develop diverse talent. In setting the standard for conducting cutting edge research, many things have changed at NIBR, but some things stay the same: a collaborative nature, a commitment to teamwork across the organization and a relentless focus on improving patient care. Do you want to be part of a global pharmaceutical leader that has reinvented the paradigm of drug development while maintaining its unwavering commitment to bringing the latest breakthrough therapies to our patients?
Minimum requirements: What you will bring to the role: PhD and 4 - 6 years of related experience in pharmaceutical/CRO/related industry •Strong scientific and operational background in ligand binding assays, qPCR techniques and cellular assays (e.g., flow cytometry, receptor occupancy and cellular immunogenicity assays) •Fundamental understanding of immunogenicity assay development and qualification. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data •Previous hands-on lab experience using various ligand binding techniques and molecular biology/biochemistry assays •Experience in software coding or instrument programming, e.g., Hamilton ML Star, and working with informatics groups to develop and implement in-house software solutions •Strong interpersonal communication skills and ability to thrive in a dynamic matrixed working environment
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