Teva Biological Researcher II - West Chester PA 

United States, Pennsylvania, East Bradford Township 

577667658

We are seeking a highly motivated individual with hands-on experience in anti-drug antibody (ADA) and neutralizing antibody (NAb) assays in support of immunogenicity assessment of biologic drug development. You will be a member of Specialty Bioanalytics at our West Chester, PA site. This site plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, early to late phase clinical studies through BLA submission and post marketing support.

• Participate in ADA and/or NAb method development in support of preclinical and clinical immunogenicity assessment
• Conduct method validation and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and summarizing data
• Perform data analysis and transfer using Watson LIMS, and assist in preparation of assay validation report or sample analysis report
• Maintain laboratory records for compliance/regulatory audits
• Procure, inventory, and track assay reagents
• Work in collaboration with sample management team to maintain sample chain of custody records

• Bachelor of Science in Immunology, Pharmacology, Biology, or a related field, with at least five years of relevant industry experience, or Master of Science in Immunology, Pharmacology, Biology, or a related field, with at least three years of relevant industry experience in the pharmaceutical, biotechnology, and/or CRO industry, including expanded levels of responsibility or a range of experiences
• Working knowledge of GLP, GCP, SOPs, and regulatory requirements is required
• Experience with ligand binding assays, cell-based assays, PK, ADA and/or NAb method development and validation, and execution of immunoassays for immunogenicity assessment
• Proficiency in Excel and laboratory data management systems, with a strong preference for Watson LIMS
• Experience using SoftMax Pro and MSD Discovery Workbench for data analysis, data summary, data transfer, and/or report writing is a plus
• Ability to work collaboratively in a diverse, fast-paced environment, with strong multitasking skills
• Excellent communication and interpersonal skills

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