Senior Executive

3 weeks ago

Vadodara India SUN PHARMA Full time

Job Description 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. - 48 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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