Job Description
We are seeking a highly skilled Separations Scientist to join our team. As a key member of our Quality Control group, you will play a critical role in ensuring the quality and integrity of our biologics drug substance.
* Main Responsibilities:
* To participate in the set up of GMP Labs, including lab design, construction, and commissioning for production of biologics drug substance.
* To perform analytical method transfer, verification/validation and routine analysis using various techniques such as HPLC/IC (Size Exclusion), CE, c IEF UV etc.
* To participate or lead activities like general lab readiness, audit readiness housekeeping laboratory equipment qualification calibration maintenance required documents preparation review SOPs protocols methods reports development stock control system implement Lean tools 5 S Kanban Kaizen risks assessments ensure tasks performed safely maintain high quality compliance safety drug Substance Lab deviation investigations CAPAs change controls train coach Separation Associate Scientists other QC personnel provide general support inventory Consistently deliver monitor specific Key Performance Indicators related duties assigned management Teamwork Communication Problem solving Training Leadership Laboratory Management Inventory control Quality assurance Regulatory Compliance Auditing Train staff Procedures documentation Science technical knowledge Chemical Biological Pharmaceutical Biochemistry Biopharmaceutical Chemistry Drug discovery Development Manufacturing Production Process Analysis Testing Validation Qualification start-up Commissioning Commercialization Business Operation Excellence Environment Improvement Continuous improvement learning Budgeting Strategic planning Project coordination administration Skills include Chemistry
HPLC/IC
CE/cIEF
Spectroscopy Tech Transfer Protocols Methods Reports Validation Pharmaceuticals Recombinant Proteins oligonucleotides recombinant cells formulation assays assays troubleshooting purification optimizing procedures High-performance Liquid Chromatography Ion chromatography Electrophoresis Spectroscopy Capillary Electrophoresis Microfluidic microchromatographic devices Nanoscale detection disease biosensors Analytical Tools Instruction
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