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Research Associate: Product Characterization

Lupin
Lupin
3-6 years
preferred by company
10 Feb. 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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


About the Role

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.


Experience Required

  • 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.


Educational Qualification (Mandatory)

  • Master’s Degree (M.Sc.) in Biotechnology or Biochemistry
    OR

  • Postgraduate specialization in Biopharmaceutics or Analytical Chemistry


Key Responsibilities

Protein & Impurity Characterization

  • 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

Bio Similarity & Data Analysis

  • 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

Method Development & Qualification

  • Plan and execute characterization experiments using LC-MS

  • Develop and qualify analytical methods

  • Prepare method development and qualification reports

Regulatory & Scientific Documentation

  • 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

Team Leadership & Collaboration

  • Guide and mentor team members in:

    • Sample preparation techniques

    • LC-MS workflows

    • Data interpretation

  • Collaborate with cross-functional teams to support integrated analytical strategies


Required Technical Skills

  • 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


Core Competencies

  • 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


Why Join Lupin Biotech?

  • 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


Equal Opportunity Statement

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.