Senior/Principal Scientist, Analytical Sciences, Biopharmaceutical Development

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POST DATE 8/11/2016
END DATE 10/23/2016

MedImmune, LLC Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


This position can be filled at either the Senior Scientist or Principal Scientist Level depending upon experience. p /p * Responsible for developing and managing a high performing team ranging from day to day activities to staff career development. br * Develop phase appropriate analytical development plan and lead activities for novel molecules (antibody drug conjugates, bispecifics, fusion proteins etc), including product characterization, physicocchemical method development/optimization/qualification, setting scientifically justifiable comparability strategies, specification and control strategies. br * Provide technical advice, critical review of experiment design and data analysis to assure the highest quality of data is developed and presented. br * Author, review and/or approve key documents such as: method and characterization reports, SOPs, comparability protocols and reports, justification of specifications, and appropriate sections of regulatory filings. br * Strong technical aptitude for the identification, development, and implementation of novel analytical technologies. Lead internal SME groups and external collaborations. br * Publish/present in high quality journals/conferences. Advance MedImmune scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences. br * Interact with Research in selecting appropriate candidate molecules. Interact with clinical and commercial QC to ensure robust method performance for release and stability testing. br * Interact with process, formulation, bioassay and lot release/stability functions to ensure strong cross functional collaborations and integrated process and product development. p /p ~BSP p /p