Manager, R&D/Sr. Manager, R&D

Company Name:
Job Description
MedImmune GMP testing group has a Manager/Sr. Manager R&D; position. Manager/Sr. Manager R&D; Bioassay group will oversee Bioassay group within GMP testing group. This candidate will coordinate and prioritize Bioassay Release and Stability testing working with the analysts in the lab. The candidate will be responsible for overseeing transfer of assays from the Development groups, perform gap analysis of the methods to ensure fit for purpose for various stages of product development and will be ultimately be responsible to transfer the assays to commercial site. He/She will make detailed observations, analyzes data, interprets results and effectively presents results at internal and external meetings. Manager/Sr. Manager candidate will mentor analysts in the lab for knowledge management and work efficiency. He/She assures that all laboratory documentation and regulatory compliance systems are maintained according to current GMP standards.
Position Requirements
At the Manager level, we require a BS with a minimum of 10-13 years of experience or an MS with 8-10 years of experience in Biopharmaceutical industry with relevant experience in lab management, troubleshooting, and tech transfer.
In addition to the above, at the Sr. Manager level, the candidate will be expected to collaborate with Development groups to evolve a strategy for potency assays and help Director/Associate Director in implementation of strategy. Sr. Manager will preferably have a Ph.D. or M.S with significant experience in lab management, experience in strategy development in addition to Bioassay experience.
Additional Notes
Management experience in a BioTech/Pharmaceutical. Ability to deal with complex problems. Good inter-personal relations.
Title: Manager, R&D;/Sr. Manager, R&D;
Location: MD, Gaithersburg - Corporate Headquarters
Req ID: 7992
Position Category: Development - Analytical Biochemistry

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