As Investigator II of the Biologics bioanalytical outsourcing group within PKS (PK Sciences) you will coordinate and monitor bioanalytical activities outsourced to external partners. You will act as the interface with the clinical teams / stakeholders.
Your responsibilities will include: • Manage and oversee the development and validation of bioanalytical assays for PK, PD and Immunogenicity assessments for Biologics, Cell and Gene therapies • Support Immunogenicity clinical strategy and data interpretation consistent with current industry and health authority expectations • Coordinate clinical sample analysis at Contract Research Organizations (CROs) according to the study needs and timelines • Perform quality oversight and review of bioanalytical data and reports from external service providers • Contribute relevant bioanalytical sections to regulatory and submission document (e.g. IB, CTD.) • Maintain understanding of current international health authority guidelines and expectations governing regulated bioanalysis • Monitor development and validation of bioanalytical assays for assigned projects • Support clinical teams in the setup of clinical trials by providing bioanalytical expertise and input on sample collection, bioanalytical methodology, bioanalytical data specifications and timelines • Work with CROs to provide relevant information to start activities (Study protocol, method descriptions, timelines) • Monitor outsourced activities at CRO during the course of the studies • Provide technical guidance to CROs on method performance, trouble-shooting as needed • Responsible for the review and acceptance of CRO data and reports • Lead Immunogenicity data interpretation within study teams • Manage communications between internal and external partners • Contribute to regulatory and submission documents
What you’ll bring to the role: • PhD • Fluent English (oral and written) • At least 2-4 year experience after your PhD in the pharmaceutical industry or CRO in the same or closely related position • Knowledge in drug development and regulatory compliance • Strong Knowledge in Bioanalytical techniques for New Biologics (cell and gene therapy) • Strong knowledge in method validation according to guidelines • Strong knowledge of Immunogenicity assessment according to guidelines
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