-- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Science or related field.
-- At least 5 years of managerial experience with an emphasis on team leadership, communication, and problem solving.
-- 5+ years of industry experience analyzing vaccines, recombinant proteins, monoclonal antibodies, fusion proteins, and/or conjugate vaccine drug candidates using the following techniques:
- HPLC and UPLC platforms.
- RP, SEC, HILIC, and IEX column chemistries.
- PDA, FLR, ELSD, MALLS, and CAD detectors.
- DLS, SLS, MALLS, A4F, AUC, and LO.
-- Expert in the use of Waters instrumentation and Empower software
-- Experience supervising the development, optimization, qualification and transfer of separation and sizing methods for release, stability, and IPC testing.
-- Demonstrated experience writing SOPs and method development, qualification, and transfer protocols and reports.
-- A deep understanding of QbD principles, with a strong emphasis on the measurement of CQAs.
-- Must be a self-starter, and be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
Same as basic.
The Senior Manager of Separation Sciences and Sizing will be integral to the establishment of analytical capabilities at the new GSK Vaccines US headquarters in Rockville, MD. The Senior Manager will be expected to lead a diverse team of highly skilled analytical scientists in the design and development of analytical methods to support the lifecycle of candidate vaccine programs. Responsibilities will also include the development and transfer of release methods for GMP testing for Phase 1 and Phase 2, according to Quality by Design principles, in partnership with the Technical Development, Quality and Regulatory teams.
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