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Senior Bioanalytical Scientist – GLP REQUIRED

  • Anywhere

Company :
Affinity Executive Search

Location :
Gaithersburg, Maryland

Expiry Date :
Sat, 19 Dec 2020 23:59:59 GMT

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Description :
LOVE YOUR JOB!

Our client is expanding and seeks a SENIOR BIOANALYTICAL SCIENTIST, supporting their gene therapy pipeline, who will

* Develop, qualify and validate robust bioanalytical methods for cell-based and ligand binding assays
* Conduct technology transfer and ensure analytical development and validation activities (conducted internally and with CROs) lead to robust methods
* Serve as the lead for the bioanalytical portion of non-regulated as well as GLP and GCP studies.
* Write and review study protocols, analytical procedures, reports for regulatory submissions.
* Perform technical reviews of analytical data and be responsible for data interpretation, analysis, and reporting of results for method development and validation.

REQUIREMENTS

* significant industry experience and demonstrated ability with execution of immunoassays including ELISA, ECL, ELISPOT and cell-based assays like qPCR, and LCMS.
* Ability to plan and perform experiments and lead internal and external functional projects
* Familiarity with statistical analysis tools and able to apply the basic statistic tools
* Knowledge with gene therapy is preferred