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Healthcare Practitioners and Technicians

Biological Researcher  West Chester, PA  Posted: 1/6/2020
Job Description

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Job Category:

Healthcare Practitioners and Technicians

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Stefanini is looking for Biological Researcher at West Chester, PA
Seeking a highly motivated individual with experience in cell-based and/or ADA assay development, and sample analysis in support of immunogenicity assessment of protein therapeutics. You will be a member of Specialty Bioanalytics, 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.
  • Participate in Cell-based and/or ADA method development, in support of preclinical and clinical immunogenicity assessment
  • Conduct method qualification 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 qualification/validation as well as sample analysis reports
  • 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

Job Requirements


  • B.S. in Immunology, Biology, Biochemistry, or a related field, with 1-3 years of relevant bioanalytical assay (cell-based, ADA, or biomarker) experience in pharmaceutical, biotechnology, and/or CRO industry.

  • Preference will be given to candidate with working knowledge of GLP, GCP and regulatory environment.

  • Experience with cell-based assays and/or ligand binding assays/ADA method development and execution of immunoassays for immunogenicity assessment is highly preferred.

  • Must be proficient in Excel and data processing. Experience with a lab data management system such as Watson LIMS is preferred.

  • 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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