Teva Pharmaceuticals USA, Inc.

Scientist I- Immunogenicity (Biologics)

US-PA-West Chester
Requisition #
17-20146
# Positions
1
Experience (Years)
5
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:

  • Co-develop and implement immunogenicity assessment strategy
  • Design, develop, and validate anti-drug antibody methods
  • Write SOP, assay development reports, assay validation reports, and other technical reports as applicable.
  • Manage sample analysis to deliver ADA testing results, including but not limited to planning assay runs in Watson, performing the assay, data summary
  • 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
  • Mentor associate scientists or research associates as required

Qualifications

 

Requirements:

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.

 

 

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