Research Associate - Product Characterization

Roles & Responsibilities
• Perform structural and functional characterization of proteins using LC-MS techniques
• Conduct impurity characterization and advanced LC-MS analysis
• Analyze and review data for biosimilarity assessment
• Plan and execute characterization experiments using advanced LC-MS applications
• Prepare, review, and present experimental data and scientific outcomes for CMC and Regulatory Affairs dossier submissions
• Draft scientific study protocols and reports related to method development, method qualification, and biosimilarity assessment
• Support cross-functional analyses such as charge variant and impurity characterization
• Review MS data, ensure accurate documentation, and report analytical results
• Prepare method development and method qualification reports
• Guide and mentor team members on sample preparation, LC-MS workflows, and data interpretation

Qualification
• Master’s degree in Biotechnology or Biochemistry
• Postgraduate degree in Biopharmaceutics or Analytical Chemistry preferred

Experience
• 3–6 years of relevant experience in protein characterization or analytical development using LC-MS

Skills
• Strong expertise in LC-MS–based protein and impurity characterization
• Experience with advanced LC-MS applications and DQA SOPs
• Knowledge of biosimilarity assessment and regulatory documentation
• Scientific writing and data interpretation skills
• Ability to mentor team members and collaborate with cross-functional teams
• Strong analytical thinking and attention to detail

About the Organization
Lupin Biotech, a part of the Lupin Group, focuses on biopharmaceutical research, development, and manufacturing excellence. The organization promotes innovation, scientific rigor, and quality-driven processes in a collaborative work environment.