Associate Scientist – Biotech R&D (Biosimilar Development)Location: Pune R&D, Maharashtra, India
Company: Lupin
Date Posted: February 5, 2026
Employment Type: Full-Time
Industry: Biopharmaceutical R&D | Biosimilar Development | Bioassays
Lupin is seeking an experienced Associate Scientist – Biotech R&D to join its Pune R&D facility, focusing on biosimilar development and functional bioassays. This role involves designing, developing, and analyzing cell-based assays, ELISAs, and flow cytometry-based assays to evaluate biologics’ mechanisms of action.
The ideal candidate will have hands-on experience with biosimilar bioassay development, data analysis, assay qualification, and regulatory-compliant documentation, along with the ability to mentor junior team members and contribute to cross-functional scientific discussions.
7–9 years of experience in bioassay development for biosimilars
Proven expertise in:
Cell-based assays and ELISA development
Flow cytometry-based functional bioassays (preferred)
Bioassay method qualification, validation, and transfer to QC
Data analysis using software tools such as PLA (equivalence testing), GraphPad Prism, and Minitab
Experience in receptor biology, monoclonal antibody (mAb) bioassays, and regulatory-compliant documentation is highly desirable.
Master’s Degree in Biochemistry, Biotechnology, or Biology
Postgraduate specialization in Biotechnology or related Life Sciences field
Develop and optimize cell-based, ELISA, and functional bioassays for biosimilars
Evaluate different mechanisms of action using novel technical approaches
Analyze assay data and interpret results accurately using statistical and software tools
Qualify and validate bioassays for regulatory submission and QC transfer
Troubleshoot experimental workflows and ensure reproducibility of results
Maintain accurate, regulatory-compliant documentation for all assays
Independently design experiments with minimal supervision
Participate in scientific discussions and contribute to cross-functional projects
Mentor junior scientists in assay techniques, data analysis, and documentation
Apply knowledge of ICH guidelines and other regulatory standards in bioassay development
Support scientific reporting for biosimilar dossiers and internal reviews
Advanced knowledge of biosimilar bioassays and functional characterization
Strong analytical and problem-solving skills
Proficiency in data analysis tools (GraphPad Prism, Minitab, PLA software)
Strong documentation, reporting, and protocol-writing abilities
Excellent collaboration and communication skills
Collaboration & Cross-Functional Alignment
Customer Centricity
Talent Development & Mentorship
Innovation & Scientific Creativity
Process Excellence & Compliance
Result Orientation
Stakeholder Management
Strategic Agility
Work on cutting-edge biosimilar research and functional bioassays
Contribute to regulatory-compliant development and QC transfer of biologics
Collaborate with a highly skilled, research-driven R&D team
Gain exposure to advanced statistical analysis and bioanalytical software tools
Lupin is committed to providing equal employment opportunities across hiring, promotion, compensation, and professional growth. All qualified applicants will be considered in accordance with applicable regulatory and employment standards.
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