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This position provides support to the Analytical Characterization Team in technical and operational activities like Trace analysis (Extractable & Leachables) using Hyphenated Advanced Analytical Techniques such as ICP-MS/OES, GC-MS and LC-MS/MS-MS. The successful candidate will need to possess sound theoretical knowledge of modern analytical techniques, updated knowledge of current Pharma industry guidance, excitement and energy for new product development impacting patients world-wide, and good written & verbal communication skills. A good learning agility will be necessary to innovatively face the challenges encountered during R&D work.
Job Responsibility:
Define, organize, plan and execute analytical development and characterization activities of pharmaceutical injectables
Work with and interpret data of advanced instrumentation techniques
Conduct failure analysis and root cause analysis
Engage in science-based troubleshooting
Provide proposals for product development related innovations
Ensure good cross-functional communication and collaboration
Preparation of scientific reports, proposals, and presentations
Perform calibration and maintenance of laboratory instruments and equipment
Follow quality and safety guidelines
Requirements:
Define, organize, plan and execute analytical development and characterization activities of pharmaceutical injectables in compliance with current international/regional/national regulations and guidance (cGLP, cGMP, GDP)
Work with and interpret data of advanced instrumentation techniques, hyphenated techniques, and other analytical techniques
Conduct failure analysis and root cause analysis in new product development and sustaining product projects within specified timelines
Engage in science-based troubleshooting of the analytical issues and product development challenges
Provide proposals for product development related innovations, analytical method innovations, and product/process improvement initiatives
Ensure good cross-functional communication and collaboration to drive allotted activities to timely completion
Preparation of scientific reports, proposals, and presentations
Perform the calibration and maintenance of laboratory instruments and equipment
Follow Baxter’s Quality Manual, SOPs, and EHS&S guidelines