Associate Scientist II, Cellular Process Development

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POST DATE 9/18/2017
END DATE 11/18/2017

bluebird bio, Inc. Cambridge, MA

Company
bluebird bio, Inc.
Job Classification
Full Time
Location
Cambridge, MA
Job Type
Regular
AJE Ref #
579556646

JOB DESCRIPTION

Provide support for method development and qualification for cell-based autologous gene therapies. Responsibilities include the following: execute strategies to qualify assays for use with autologous, ex-vivo gene therapy products; conduct hands-on assay development and qualification activities; contribute to method development/qualification protocols and reports; support Quality Control organization in addressing deviations and laboratory investigations; provide support to the process characterization group and assist in various assays such as flow cytometry, DNA/RNA extractions and PCR; assist in compilation and analysis of study generated data; maintain accurate and reliable record keeping including batch records, notebooks, and all other pertinent documentation; and manage testing at CTO laboratories.

Requirements:

Must have MS in biochemistry, biotechnology or related field and 2 years of industry/academic research experience with cell-based, ex-vivo gene therapy and method development and qualification, including experience with the following: ELISA, PCR and other analytical techniques; lentiviral vectors; determining method accuracy, precision, linearity, LOD/LOQ as required by ICH guidelines; mammalian cell culture; development of cell-based assays, including potency assays; working in a GMP QC lab; managing testing programs at CROs/CTOs; authoring method development and qualification protocols and reports, as well as SOPs; working with FDA/EMA/ICH regulations and guidance on method development. Will also accept a BS and 5 years of experience in stated areas.