18 hours
2017-12-142018-01-12

Scientist I- Immunogenicity (Biologics)

Teva Pharmaceuticals
Ashburn, PA
  • Job Code
    17-20146
Careers - Teva Pharmaceuticals in the US -Scientist I- Immunogenicity (Biologics)

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, 
  • M.S. in a related field with a minimum of 8 years,
  • 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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Scientist I- Immunogenicity (Biologics)

Teva Pharmaceuticals
Ashburn, PA

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Teva Pharmaceuticals
Ashburn, PA

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