Teva Pharmaceuticals USA, Inc.

Research Associate - Immunogenicity, Biologics (West Chester, PA)

US-PA-West Chester
Requisition #
17-20431
# Positions
1
Experience (Years)
3
Category
Research & Development - Pharmaceutical

Overview

We are seeking a highly motivated individual with experience in anti-drug antibody (ADA) assay development, validation and sample analysis in support of immunogenicity assessment of biologicis. You will be a member of Biologics, Assays and Technology, 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

 

  • Develop ADA method, in support of preclinical and clinical immunogenicity assessment
  • Conduct method validation and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and data summary
  • Perform data analysis using Watson LIMS, data transfer, and assist in preparation of assay validation report, and sample analysis report
  • Maintain laboratory records for compliance/regulatory audits
  • Procure, inventory, and track assay reagents
  • Help sample inventory in collaboration with sample management team and maintain sample chain of custody records

Qualifications

 

  • MS in Immunology, Pharmacology, Biology, or a related field with a minimum of 1 year, or a B.S. in a related field with a minimum of 3 years of bioanalytical experience in pharmaceutical, biotechnology, and/or CRO industry.
  • Must have working knowledge of GLP, GCP, SOPs and regulatory requirements.
  • Experience with ADA method development and validation, and execution of immunoassays for immunogenicity assessment is highly preferred.
  • Must be proficient in Excel as well as a lab 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 diverse, fast-paced environment with ability to multi-task. Good communication and interpersonal skills are required.

 

 

 

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