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