Job Title: Senior Executive-Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G11B Location: Vadodara At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Objective SeaLooking for highly motivated candidate having technical expertise in Biosimilar product characterization. Key Responsibilities: • The candidate is expected to develop LC-MS based methods for protein and peptide product characterization. • The candidate is expected to qualify the methods for intended purpose for all pipeline products. • The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. • Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc. • Preparation and review of method development reports (MDR) and analytical test procedures (ATP). • Perform in-depth data analysis of LC-MS results and interpret findings to support product development and quality assessments • Work closely with upstream and downstream process development teams to provide analytical insights Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. • The candidate is responsible for the operation and maintenance of the MS instruments • To manage chemicals, consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues. • Responsible for managing the regulatory queries. • The candidate is expected to draft the technical content for regulatory dossier. Travel Estimate NA Job Requirements Educational Qualification M.Sc/M.Tech Experience 2-6 years of relevant experience Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).