Associate Scientist – Bioanalytical Research (Large Molecules)
Location: Pune (R&D), Maharashtra, India
Company: Lupin
Date Posted: February 9, 2026
Employment Type: Full-Time
Industry: Biopharmaceutical Research | Bioanalysis | Clinical Development
About the Role
Lupin is seeking an experienced Associate Scientist – Bioanalytical Research to support large molecule drug development programs at its Pune R&D facility. This role focuses on bioanalytical method development, immunogenicity testing, pharmacokinetic (PK) analysis, and biomarker assay execution for clinical and regulatory submissions.
The ideal candidate will have strong expertise in ligand binding assays (LBA), ADA/NAb assay development, large molecule bioanalysis, and clinical sample analysis within regulated environments.
Experience Required
5 to 7 years of experience in:
Bioanalytical method development and validation
Large molecule in vivo PK analysis
Biomarker assay development
Immunogenicity testing (ADA and NAb assays)
Clinical study sample analysis for regulatory submissions
Experience working in GLP-compliant laboratories and supporting global regulatory filings will be preferred.
Educational Qualification (Mandatory)
Master’s Degree (M.Sc.) in Biotechnology or related Life Sciences discipline
Key Responsibilities
Bioanalytical Method Development
Develop and validate bioanalytical methods for large molecules
Design and optimize assays for:
In vivo pharmacokinetic (PK) analysis
Biomarker detection
Anti-Drug Antibody (ADA) assays
Neutralizing Antibody (NAb) assays
Utilize advanced immunoassay formats including:
Competitive Ligand Binding Assays (LBA)
SPEAD techniques
Acid Dissociation (ACE) methods
Clinical Sample Analysis
Analyze clinical study samples in compliance with regulatory standards
Ensure data accuracy and readiness for regulatory submissions
Instrumentation & Laboratory Operations
Operate and maintain instruments such as:
ELISA Reader
Meso Scale Discovery (MSD) platforms
pH meters
Analytical balances
Pipettes
Troubleshoot analytical instrumentation and resolve technical issues
Quality & Collaboration
Ensure smooth functioning of laboratory workflows
Maintain high-quality result analysis and documentation standards
Collaborate with cross-functional departments and external bioanalytical partners
Contribute to regulatory documentation and audit readiness
Required Skills & Competencies
Strong knowledge of large molecule bioanalysis and immunogenicity testing
Hands-on experience in ADA and NAb assay development
Familiarity with global regulatory expectations for bioanalytical data
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Ability to work collaboratively in multidisciplinary teams
Core Competencies
Technical Expertise in Bioanalysis
Analytical Thinking
Attention to Scientific Detail
Cross-Functional Collaboration
Regulatory Compliance Awareness
Result Orientation
Why Join Lupin?
Work on advanced biologics and large molecule development programs
Contribute to global clinical and regulatory submissions
Gain exposure to cutting-edge bioanalytical technologies
Be part of a research-driven pharmaceutical organization
Equal Opportunity Statement
Lupin is committed to providing equal employment opportunities across hiring, compensation, promotion, and professional development. All qualified candidates will be considered in accordance with applicable employment regulations.
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