Senior Executive

3 weeks ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

Key Responsibilities Analytical Method Development Validation Develop and validate robust HPLC methods for characterization and quantification of biological products e g monoclonal antibodies recombinant proteins Perform method optimization robustness studies and transfer protocols as per ICH guidelines Routine Stability Testing Conduct analysis of in-process release and stability samples using HPLC UPLC Capillary and Gel Electrophoresis UV spectrophotometric methods Host Cell DNA quantification e g qPCR-based methods HCP ELISA and other immunoassays Instrument Operation Maintenance Perform routine maintenance calibration and troubleshooting of analytical instruments including HPLC electrophoresis systems spectrophotometers and ELISA readers Ensure timely qualification and performance verification of instruments Documentation Compliance Prepare and review SOPs STPs protocols reports and analytical records in compliance with regulatory requirements Maintain accurate and complete documentation in laboratory notebooks and electronic systems Quality Regulatory Compliance Participate in internal and external audits and support regulatory submissions with analytical data Cross-functional Collaboration Work closely with R D Quality Control and Regulatory Affairs teams to support product development and lifecycle management Provide technical support during investigations deviations and CAPAs Training Development Train junior analysts and new team members on analytical techniques and laboratory practices Stay updated with advancements in analytical technologies and regulatory expectations Qualifications Experience M Sc M Tech M Pharm in Biotechnology Biochemistry or related life sciences discipline 4-8 years of relevant experience in analytical development or QC of biopharmaceuticals Hands-on experience with HPLC method development and ELISA based techniques Familiarity with regulatory guidelines ICH FDA EMA and quality systems Key Skills Strong analytical and problem-solving skills Attention to detail and data integrity Excellent documentation and communication abilities Proficiency in software tools like Empower Chromeleon SoftMax Pro etc Ability to manage multiple projects and meet deadlines

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