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Scientist – Bioassay Development
* Undertake original research that includes developing and confirming highly sensitive, reliable bioassay and immunoassay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues.
* Perform complex bioanalytical methods on biological matrices.
* Apply and interpret scientific theories, concepts, techniques, and regulatory requirements in bioanalytical studies
* Act as research scientist, in a team work setting, on complex bioanalytical projects.
* Produce reports for reliable, sensitive, and validated methods of analyses.
* Participate in client visits.
* Prior experience working in a regulated GLP or GMP compliant environment is preferred.
* Hands on experience in developing cell based assays applicable to Potency and Immunogenicity studies is required.
* Hands on experience in one or more immunoassay techniques (Ligand-binding assay: ELISA, MSD, Biacore and/orRIA) applicable to Potency, Pharmacokinetic and Immunogenicity studies is preferred.
* Experience in mammalian cell culture and broad knowledge in cell biology.
* Experience developing and validating Immunogenecity (ADA assay and Nab assay) is preferred.
* Familiar with FDA Bioanalytical method validation guidance
* Knowledge Data Reduction Software (e.g. Softmax, GraphPad and StatLIA etc).
* Have strong communication skills both writing and oral presentations with strong interpersonal skills and ability work in a fast-moving environment.
* Ph.D in Biochemistry, or Cell Biology with 2+ years of related industry experience or a BS or MS degree plus 5-8 years of related hands-on laboratory experience. CRO experience is preferred.
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