Teva Pharmaceuticals USA, Inc.

Senior Scientist - Immunogenicity Assessment, Biologics West Chester, PA

US-PA-West Chester
Requisition #
17-20305
# Positions
1
Experience (Years)
7
Category
Research & Development - Biopharmaceutics

Overview

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.  

 

 

Responsibilities

Responsibilities:

  • Serve as Contributing Scientist role for pre-clinical and clinical immunogenicity sample testing
  • Co-develop and implement immunogenicity assessment strategy
  • Lead junior scientist and/or research associates in matrix teams to develop, and validate anti-drug antibody methods
  • Author assay development reports, assay validation reports, and other technical reports as applicable.
  • Conduct data analysis and author bioanalytical (sample analysis) reports
  • Present assay strategy and data within or across department
  • Lead compliance effort for applicable bioanalytical activities
  • May serve as subject-matter expert in a study team

Qualifications

 

Requirements:

 

 

  • Ph.D  in Immunology, Pharmacology, or a related field with a minimum of 5 years of bioanalytical experience in pharmaceutical, biotechnology, and/or CRO industry - STRONGLY PREFERRED
  • M.S. in a related field with a minimum of  10-12 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 in preparation of documents related to immunogenicity assessment, including but not limited to 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.
  • Hands-on experience with automation system and electronic notebook 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.

 

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