Scientist, Analytical Development Platform
Within the Analytical Development US, the Scientist will serve as Subject Matter Expert (SME), in the Analytical Platform of Mass Spectrometry and Spectrophotometry, be responsible of the design and development of analytical methods, using Quality by Design (QbD) principles, to support drug substance/drug product characterization, product and process development and/or, the development and transfer of release methods for GMP testing, for the entire local US product portfolio of TRD.
• Develop, qualify, and execute analytical methods, in the analytical technological platform of Mass Spec & Spectrophotometry, according to the Analytical Target Profile through the understanding of CQAs
-Qualitative and quantitative characterization of recombinant or synthetic viral vaccine candidates in pre-clinical and Phase 1-3 stages
-Develop and implement assays for supporting upstream/downstream and formulation development
-Perform criticality confirmation studies for quality attributes
• Deliver GMP release testing methods, in the analytical technological platform of Mass Spec & Spectrophotometry and transfer to GMP testing group in compliance with relevant Quality and scientific expectations
• Deliver the antigen and product characterization needs to other Technical R&D and Preclincial R&D functions, using state-of-the-art technologies for analytics and data interpretation
-Support for antigen design, preclinical characterization, process understanding and testing of non-GMP DS & DP
• Manage the technical aspects of his/her roles
-Keep up-to-date with relevant scientific and technological development by attending scientific conference/training/workshop and regular literature review
-Provide vision and leadership in technology innovation
-Interact with QA/QC, DS/DP teams, and project management to discuss characterization/assay related issues
-Manage external collaborations and networks, including outsourcing
• Author study protocols, technical reports, and/or scientific manuscripts for publication
-Ensure all experimental procedures and documentations are compliant with highest quality and regulatory standards
-Represent the his/her Analytical Development Platform and ARD to present results to senior management and peer colleagues at cross-functional meetings
-Ph.D. or equivalent in biological, analytical , or pharmaceutical chemistry, or similar field plus 2 years of industry experience
-In-depth understanding of protein chemistry and strong laboratory skills are required
-Hands-experience with qualitative and quantitative characterization of recombinant proteins, lipids, and/or oligonucleotide using mass spectrometry and spectrophotometry (protein analysis)--(ICP, UV, IR, CD, DSC, Fluo)
-The incumbent should be a detail-oriented self-starter and be able to work independently under minimum supervision
-Strong communication skill (presentation and written) is a must
-Knowledge and experience with Quality by Design, Process Analytical Technology, CMC, regulatory filling, and/or project management is preferred
-Experience with small molecule extractable & leachable analysis is preferred
-Experience with mid-to-late phase clinical development will be a strong plus
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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