Sign In
 [New User? Sign Up]
Mobile Version

Sr. Scientist, Immunogenicity Assessment - Biologics

Teva Pharmaceuticals USA


Location:
West Chester , Pennsylvania 19380
Date:
08/09/2017
2017-08-092017-09-08
Job Type:
Employee
Job Status:
Full Time
Teva Pharmaceuticals USA
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

 

Teva Biologics in West Chester, PA:  With a world-class global biologics R&D team and an exciting pipeline of potential new medicines, there has never been a better time to be in Teva's Biologics R&D group – and West Chester is at the heart of it all.

 

We are rapidly expanding our biologics hub here and have some amazing opportunities for talented people. West Chester is home to our CMC and Bioassay centers of scientific excellence, housed in state of the art facilities with full GMP production capability. To support this work we have designed and built cutting edge Process Development, Quality control, Bioanalysis, Potency Bioassay and Analytical Development/Characterization labs.

Currently we are  seeking a Sr. Scientist, Immunogenicity Assessment.  We need 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.  

Position Overview:  

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

Requirements


 

Ph.D. in Immunology, Pharmacology, or a related field with a minimum of 5 years, or a M.S. in a related field with a minimum of 10 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.

 

 

 

Powered By

Featured Jobs[ View All ]