Senior Manager, Product Analytics

Senior Manager, Product Analytics
+ Requisition ID:WD55272
+ Position:Full time
+ Open date:Jul 14, 2016 12:43 PM
+ Functional area:Science and Technology
+ Location:Maryland
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+ + Required degrees:Doctorate
+ Experience required:10 years
+ Relocation:Yes
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Basic qualifications:Requires a Ph.D. in biological, analytical , or pharmaceutical chemistry, or similar field. Requires a minimum of 10 years experience in analytical development and product characterization of recombinant proteins, monoclonal antibodies, fusion proteins, conjugates and/or vaccines drug candidates.
Strong influencing and communication skills with an understanding of the cross-functional facets of development (Product and Process Development, Regulatory, QC).
Preferred qualifications:. At least 5 years of experience in managing a group.
Team leadership and problem solving with an understanding of the cross-functional facets of development (Product and Process Development, Regulatory, QC).Proven ability to manage an analytical group.
Good communication and influencing skills within Global Analytical group (Analytical Development Platforms, product Analytics, GMP Testing, Operation Support) and outside (DS, DP, RA, QC)
Details:Within the Analytical R&D group, the Senior Manager, Product Analytics will be in charge of Leading and implementing the global analytical strategy of her/his products portfolio (2-4 projects), in alignment with the GSK Vaccines R&D and Technical Research & Development strategies, and in accordance with Quality by Design (QbD) principles. This will include the design and development of analytical methods, the support of product and process development and, the development and transfer of release methods for GMP testing for Phase 1 and Phase 2, according to Quality by Design principles, and in partnership with Technical Development functions, Quality and Regulatory.
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