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Scientist - II (Associate)
Ref No.: 18-07716
Location: West Point, Pennsylvania
Description: *This is not a lab based position* This position will support Client's Regulated Biologics and Vaccines Bioanalytics Outsourcing group in the Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (PPDM). We are seeking a motivated individual with established experience in bioanalytical assay development and validation and project management skills to provide short-term support with activities related to outsourcing of biologics PK, ADA, and neutralizing antibody assays and vaccines ligand binding, cell-based, and molecular assays to support vaccines efficacy and safety. Job responsibilities will support third party lab operational oversight activities including contracting, reagent shipments, meeting organization, and performance assessments to ensure quality, timeliness and compliance of outsourced bioanalytical work. In addition, the hired candidate will support the development and maintenance of various tracking tools for the group, including spreadsheets for tracking future studies/future work and regulatory submissions, group team site setup, and vendor performance compilation and roll-up. Candidate must have experience working in a regulated assay environment and have familiarity with regulatory agency bioanalytical guidance.

Quals--
Education/Experience: • Bachelor's degree in Biology, Cell Biology, Immunology or related field with 3+ years experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays. • Proficiency with Microsoft Excel, Word and PowerPoint. Experience with Spotfire desired. • Candidate must have experience working in a regulated assay environment and have familiarity with FDA bioanalytical guidance requirements. • Position can be based in West Point or Kenilworth, but for a less experienced individual placement in WP is preferred.