Expert Scientist, Separation Sciences & Sizing
- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Science or related field.
- 7 plus years of industry experience analyzing vaccines, recombinant proteins, monoclonal antibodies, fusion proteins, conjugate vaccine drug candidates and vaccine adjuvants using the following techniques:
- Experience with HPLC and UPLC platforms; RP, SEC, HILIC, and IEX column chemistries; PDA, FLR, ELSD, MALLS, and CAD detectors; DLS, Zeta potential, MALS and LO.
- Expert in the use of Waters and Agilent HPLC and UPLC instrumentation and Empower and OpenLab software
- Extensive experience on method development, optimization, qualification and transfer of separation and sizing methods for release, stability, and IPC testing of both protein and small molecule samples.
- Demonstrated experience writing SOPs and method development, qualification, and transfer protocols and reports.
- Good understanding of QbD principles and DOE, 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.
- Strong problem solving and data interpretation capability.
The expert scientist of Separation Sciences and Sizing will be integral to the establishment and expansion of analytical capabilities at the new GSK Vaccines US headquarters in Rockville, MD. The expert scientist will be expected to work independently and collaboratively 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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