Research Associate – Product Characterization (LC-MS | Biologics)Location: Pune Biotech, Maharashtra, India
Company: Lupin
Date Posted: February 8, 2026
Employment Type: Full-Time
Industry: Biopharmaceutical R&D | Product Characterization | Analytical Sciences
Lupin is seeking a skilled Research Associate – Product Characterization to join its Biotech division in Pune. This role focuses on structural and functional characterization of proteins using advanced LC-MS platforms, supporting biosimilar development and regulatory submissions.
The position is ideal for professionals with hands-on experience in mass spectrometry-based protein analysis, impurity characterization, bio similarity assessment, and CMC documentation within a regulated biopharmaceutical environment.
3 to 6 years of relevant experience in:
LC-MS based protein characterization
Impurity profiling and structural analysis
Bio similarity assessment and comparative analytical studies
Method development and qualification in biologics
Experience in supporting regulatory submissions (CMC/RA dossiers) is preferred.
Master’s Degree (M.Sc.) in Biotechnology or Biochemistry
OR
Postgraduate specialization in Biopharmaceutics or Analytical Chemistry
Perform structural and functional characterization of proteins using LC-MS
Conduct impurity characterization studies using advanced mass spectrometry techniques
Support charge variant analysis and cross-functional impurity profiling
Analyze and review data for biosimilarity assessment
Interpret MS data and ensure accurate documentation of analytical results
Maintain compliance with DQA SOPs and quality standards
Plan and execute characterization experiments using LC-MS
Develop and qualify analytical methods
Prepare method development and qualification reports
Draft and review scientific study protocols and technical reports
Prepare presentations and documentation for CMC and Regulatory Affairs (RA) dossier submissions
Ensure regulatory-ready documentation standards
Guide and mentor team members in:
Sample preparation techniques
LC-MS workflows
Data interpretation
Collaborate with cross-functional teams to support integrated analytical strategies
Advanced knowledge of LC-MS applications for protein characterization
Strong expertise in impurity analysis and structural elucidation
Experience in biosimilar analytical comparability studies
Familiarity with regulatory documentation and CMC requirements
Strong data interpretation and report-writing skills
Collaboration and Cross-Functional Alignment
Customer Centricity
Talent Development and Mentorship
Innovation and Scientific Curiosity
Process Excellence and Compliance
Result Orientation
Stakeholder Management
Strategic Agility
Contribute to biosimilar and biologics product development
Work with advanced LC-MS analytical technologies
Gain exposure to global regulatory submissions
Be part of a research-driven biopharmaceutical environment
Lupin is committed to equal employment opportunities in recruitment, promotion, compensation, and professional growth. All qualified applicants will be considered in accordance with applicable employment regulations.
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