The opportunity
Teva’s Global Research & Development (R&D) organization supports development of a broad pipeline of products, including innovative medicines, biosimilars, and complex generics.
As Senior Scientist, Humoral Immunogenicity, we are seeking a highly motivated individual with a strong foundation in team leadership and bioanalytical assay development to contribute to our humoral immunogenicity group in the development, validation, and execution of anti-drug antibody assays. You will be a leader within Specialty Bioanalytics at our West Chester, PA location, and play a critical role in drug development from early stage research to BLA and IND submissions and post marketing support.
In this role you will lead a team of 3 analysts tasked with the design, development, troubleshooting, and execution of the assays to support immunogenicity evaluation in pre-clinical and clinical studies. You will also serve as a representative and subject matter expert on project teams for Teva Biologics programs liaising with internal and external groups on project status. As a member of the Specialty Bioanalytics department, you will also be responsible for writing study plans, study reports, BLA/IND submission documents, and SOPs.
How you’ll spend your day
Key Responsibilities:
• Directly manages a team of 3 analysts and cultivates that team within a matrixed environment
• Design and develop novel ligand binding assays for evaluation of anti-drug antibodies and incorporate improvements into existing processes
• Provide clear and concise written and oral presentations to internal and external stakeholders, including reports supporting regulatory submissions
• Rises to the challenges of a dynamic development landscape through exemplary leadership and application of strategic versatility
• Minimum expectations of 4 days on site (West Chester, PA)