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15 hours ago
Job Title ScientistJob Location Chennai Tamil Nadu IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level AssociateJob Summary Summarize the primary purpose key accountabilities of the job function Responsible for Analytical Method development Method Validation Method transfer Investigation through DMAIC approach Regulatory support Routine analytical and stability study support for API Intermediates and different DP formulations with minimal no supervision Provide the technical training to junior scientist Trouble shooting Stakeholders management Job Responsibilities Indicate the primary responsibilities critical to the job function Role Responsibilities Perform method development validation transfer Investigation regulatory support API qualification Characterization and reaction monitoring support under safety and quality compliance to enable Breakthroughs that change in patients life Delivery of Method remediation Investigations Method validations NNO assessments Method transfer and Tech support to Network sites Develop relationships with customers and stakeholders to ensure global support for changes with a wider impact for the product value stream Participate in technical investigations by applying Six Sigma methodology Analytical data review eLN review Scientific protocol and report preparation Review and understand newer technology and its implementation in the projects Ensure compliance to cGMP GSP organizations procedures and practices Ensure effective safety systems are implemented on the premises Target Zero safety incidents in the Laboratory and working areas Review of electronic Notebook of Analytical scientist data Investigation of analytical testing failures i e OOS OOT through DMAIC tools Procurement of standards and Impurities from Vendor and verification of characterization data Planning and execution of stability study Program for Development batch samples Temperature Excursion Freeze thaw studies Qualifications Skills Education - Experience - Additional Requirements Indicate qualifications and skills that are necessary for performance of responsibilities including education relevant experience licenses certifications and other job-related technical and managerial skills MSc M Pharm Ph D in Chemistry or Analytical Chemistry with 6 to 10 years of experience in Analytical development Method validations Impurity isolation Characterization Life cycle management and Transferring new technologies to network sites Experience in working in Analytical development in Drug substance and drug product background with a good knowledge of Analytical research and development is strongly preferred Understanding of Analytical chemistry Organic chemistry and Hyphenated equipment Exposure to the fundamental of user-friendly analytical methods All techniques which is user friendly and good process capability from an Analytical perspective to ensure CQ Labs will release the commercial batches on time without any bottlenecks Familiarity with all essential analytical techniques e g Wet chemistry HPLC GC Mass spectroscopy Regulatory requirements Dissolution FTIR and UV Vis Communication and listening skills Organizational Relationships Provide the primary groups or key role s that this role will interact with as a regular part of the job responsibilities Include any external interactions as appropriate Small Molecule Technology Global Technology Engineering Launch Excellence Pfizer Manufacturing Sites External Supply Global Supply Chain Regulatory Sciences Global EHS Procurement Pharmaceutical Sciences Small Molecule Contract Research Development and Manufacturing Organizations Academic Institutes Work Location Assignment On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates Research and DevelopmentLifelancer is a talent-hiring platform in Life Sciences Pharma and IT The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains For more details and to find similar roles please check out the below Lifelancer link
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