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Biological Researcher
4 weeks ago
Contract
West Chester, Pennsylvania, US

Job Description

Job Title         : Biological Researcher I

Location         : West Chester, PA 19380

Months           : 6+ Months

 

Job Description:

We are 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.

 

Responsibilities:

  • 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

 

Qualifications

  • 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.

Job Requirements

immunoassays , cell culture, cell based assays, LIMS

 

Job Code: 50062108

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