We are seeking a highly motivated Biological Researcher III (Associate Scientist) with experience in in vitro immunogenicity risk assessment of biological therapeutics. You will be a member of Teva Specialty Bioanalytics 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.
Evaluate, develop, and implement state of the art bioanalytical technologies, methods, and strategies for measuring anti-drug antibodies (ADA) and neutralizing antibodies (NAb) to support non-clinical and clinical studies.
Author reports for assay development, validation, sample analysis, and other technical reports as applicable.
Manage sample analysis to deliver ADA testing results, including but not limited to planning assay runs in Watson LIMS, performing the assay, and summarizing data.
Conduct data analysis. Present assay strategy and data within or across department.
Author bioanalytical reports for assay development, validation, sample analysis, and other technical reports as applicable.
Lead compliance effort for applicable bioanalytical activities.
A B.S. in Immunology, Biochemistry, Pharmacology, or a related field with a minimum of 7 years of relevant experience in pharmaceutical, biotechnology, and/or CRO industry; or a M.S. with 5 years of relevant experience.
Must have working knowledge of GLP, GCP, SOPs, and regulated requirements.
Experience with ADA and NAb method development, validation, and execution of assays for immunogenicity assessment.
Must be proficient in Excel as well as a laboratory data management system, with strong preference for Watson LIMS.
SoftMax Pro for data analysis and data summary as well as data transfer and report writing is a plus.
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.
Internal Number: 1463
About Teva Pharmaceutical Industries Ltd.
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!