Associate Scientist I / Associate Scientist II, GMP Testing

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POST DATE 8/28/2016
END DATE 10/23/2016

MedImmune, LLC Gaithersburg, MD

Company
MedImmune, LLC
Job Classification
Full Time
Company Ref #
360476
AJE Ref #
576009023
Location
Gaithersburg, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p This position can be filled at either the Associate Scientist I or II level depending upon experience. /p p The Analytical Sciences department in MedImmune, Gaithersburg is seeking motivated candidates to perform analytical testing of clinical stage biopharmaceutical products in accordance with cGMP regulations. /p p The individual must have prior experience with immunoassay based analytical techniques (such as ELISA, SPR or multiplex assays). Prior experience in a GMP quality control laboratory and/or regulated industry environment is required. Ability to work in a team environment, and strong verbal and written communication skills are also necessary. Additional experience with chromatography (SEC, RPLC, IEC), electrophoresis (cIEF, cGE) or device functionality (e.g. break-loose/glide-force) methods in a quality control environment is also desirable. /p p Responsibilities: /p ul li Test API and final drug substance and drug product according to written procedures following cGMP practices /li li Execute testing to support method qualification and technology transfer /li li Author, revise and/or review SOPs, protocols, reports and other relevant documentation /li li Evaluate new methods and/or technology for suitability in a GMP environment /li li Maintain laboratory and equipment in accordance with written procedures /li li Train laboratory personnel /li li Perform analytical quality investigations (deviation, OOS), as needed /li li Prepare reports and presentations for internal and external meetings and to support regulatory filings /li li Participate in and/or lead cross-functional teams /li /ul ~BSP p /p