Executive - Biotechnology

About This Role

This executive role in biotechnology focuses on developing and qualifying LC-MS based methods for protein and peptide product characterization. It involves designing and implementing integrated strategies for qualitative and quantitative assessment of product-related variants and impurities, and managing regulatory queries. The position suits a candidate with expertise in advanced analytical techniques and regulatory documentation in the pharmaceutical industry.

Responsibilities

• Develop LC-MS based methods for protein and peptide product characterization
• Qualify methods for intended purpose for all pipeline products
• 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 regions and preparation of quality target profile
• Design advanced 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.
• Prepare and review method development reports (MDR) and analytical test procedures (ATP)
• Operate and maintain analytical laboratory in compliance with GLP regulations
• Operate and maintain MS instruments
• Manage chemicals, consumables & critical reagents inventory
• Perform calibration of instruments and equipment
• Troubleshoot instrument performance and equipment issues
• Manage regulatory queries
• Draft the technical content for regulatory dossier

Requirements

• MSc or M.Tech in Biotechnology or Biochemistry
• Master's degree (M.Sc./M.Tech.) in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline with 4-7 years of relevant industry experience

Benefits

• Robust benefits and opportunities to foster personal and professional growth

About the Company

Sun Pharma is a pharmaceutical company committed to fostering an environment where employees can grow, take charge of their journey, and thrive in a supportive community.