We are seeking a highly motivated individual with experience in anti-drug antibodies assay development, validation and implementation in support of immunogenicity assessment of biological therapeutics. You will be a member of Teva Biologics, Assays and Technology team, which plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.
Ph.D. in Immunology, Pharmacology, or a related field with a minimum of 3 years, or a M.S. in a related field with a minimum of 8 years, or a B.S. in a related field with a minimum of 12 years of bioanalytical experience in pharmaceutical, biotechnology, and/or CRO industry.
Hand-on experience in development, optimization, validation, and execution of immunoassays for immunogenicity assessment is required. Experience with microparticle-based assay development is a plus. Experience in preparation of documents related to immunogenicity assessment, including method validation reports, and sample analysis reports, as well as knowledge of regulatory guidelines related to immunogenicity assessment are expected. Proficient in Microsoft Office, SoftMax and Watson LIMS. The candidate must be able to work collaboratively in a multi-cultural fast-paced environment with ability to handle multiple tasks. Good communication and interpersonal skills are required.