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We are looking to fill a new Senior Analytical Scientist/ Investigator position in the GSK Global Manufacturing Science and Technology (MSAT) Analytical Science Asia Hub as part of our expanded remit to support GSK vaccine development. In this role, you will focus on leading/ supporting the set-up and qualification of a state-of-the art analytical science laboratory and implementation of cutting-edge, advanced analytical technologies for vaccines drug substances and intermediates from pre-launch to late product lifecycle.
Job Responsibility:
Analytical Leadership and Innovation: Spearhead the full spectrum of analytical activities, including setting up advanced equipment, analytical method technology transfer and optimization, non-routine characterization and comparability assessments of drug substances and intermediates to support development and commercial manufacture of new vaccines products
Data-Driven Insights and Recommendations: Pro-actively generate and interpret comparability data of drug substances/ intermediates as part of material and process changes/ improvements to drive high impact, data-driven recommendations for the development and optimization of manufacturing processes
Problem-Solving and Root Cause Analysis: Lead laboratory investigations and trouble-shooting related to analytical equipment, methods and out-of-trend results, ensuring timely resolution with effective corrective and preventive actions
Development of Robust Analytical Strategies: Review and improve analytical methods, procedures and standards in accordance with pharmacopoeia requirements and in-house analytical technical standards
Analytical Equipment Stewardship: Qualification and lifecycle maintenance (including preventive maintenance/ calibration and performance verification checks) of equipment to appropriate analytical standards
Lifecycle Data Management: Ensure thorough, complete and accurate documentation of all laboratory procedures and data
Champion for Laboratory Safety and Sustainability: Lead/ support environmental health, safety and sustainability activities for the laboratory
Mentorship and Development: Supervise, train and develop interns and junior scientists
Requirements:
At least a degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Biochemistry/ Biotechnology, Biomedical Engineering or equivalent
Extensive hands-on experience in an analytical environment, preferably in the pharmaceutical industry with understanding of GMP and GLP requirements or equivalent
Prior experience in analytical technologies for the analysis and characterization of small molecules, biologics or vaccines is preferred
Hands-on experience, skilled in the execution, optimization and trouble-shooting in one or more of the following analytical techniques is preferred: Chromatographic techniques (2D-ULPC, HPLC-CAD, SEC-MALS), real time multi-angle light scattering (RT-MALS), analysis of biomolecular interactions by bio-layer interferometry (BLI), fluorescence-based assays, spectrophotometric techniques and colorimetric assays, dynamic light scattering (DLS), protein content by Lowry assay, nucleic acid content determination by fluorometry
Basic knowledge of drug substance and/ or drug product manufacturing processes for vaccines products is preferred
Enjoy working in a laboratory environment and thrive in activities and tasks related to analytical method development, troubleshooting, optimization, problem solving and root cause analysis under time pressure, to meet business needs and project implementation timelines
Excellent inter-personal communication skills, proactive with leadership skills, data-driven decision making, project management and stakeholder management skills with the experience and ability to work in cross-functional and global teams (across R&D, quality and global analytical hubs)
Possess a continuous improvement mindset and be able to lead improvement initiatives
Nice to have:
Experience working in multidisciplinary project teams in a fast-paced environment
Prior experience mentoring or training junior staff