Lead Scientist – Bioanalytical (Immunoassay & Biologics)
Location: Bangalore
Company: Syngene International Ltd.
Division: Discovery Services
Employment Type: Full-Time
Job Overview
Syngene International Ltd. is seeking a Lead Scientist – Bioanalytical to drive immunoassay-based bioanalytical research within a GLP-compliant laboratory environment. This role focuses on method development, validation, and sample analysis for immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) studies, supporting biologics and biosimilar development programs. The position requires strong technical expertise in ligand binding assays and surface plasmon resonance (SPR) technologies, along with leadership in ensuring data quality, compliance, and operational excellence.
Experience Required
3–6 years of relevant experience in bioanalytical or immunoassay laboratories, preferably within a CRO or regulated GLP environment.
Key Responsibilities
Lead method development and validation for immunogenicity, pharmacokinetics, and pharmacodynamics using ligand binding assays and SPR technology
Perform sample analysis for biologics and biosimilars, ensuring accuracy, consistency, and compliance with study protocols
Document, compile, and review experimental data in accordance with GLP standards and regulatory requirements
Ensure adherence to study plans, SOPs, and all applicable guidelines prior to initiating study activities
Maintain high-quality raw data records and ensure audit readiness at all times
Identify, document, and communicate deviations from study plans or SOPs to Study Director/Principal Investigator in a timely manner
Prepare and maintain SOPs, assay records, laboratory notebooks, and equipment logbooks
Support preparation of equipment qualification and validation documentation
Collaborate with cross-functional teams and communicate study progress effectively to stakeholders
Ensure compliance with laboratory safety practices, waste management procedures, and EHS standards
Contribute to both GLP and non-GLP studies as required by project needs
Educational Qualification
Master’s degree in Biological Sciences, Biochemistry, or a related discipline
Technical Skills
Hands-on expertise in ligand binding assays (LBA) and immunoassay platforms
Experience with surface plasmon resonance (SPR) for biologics characterization
Strong understanding of pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity assessments
Working knowledge of GLP regulations, bioanalytical method validation, and regulatory compliance
Proficiency in scientific documentation, data analysis, and laboratory systems
Core Competencies
Strong analytical thinking and problem-solving skills
High level of accuracy, data integrity, and attention to detail
Effective communication and collaboration across multidisciplinary teams
Ability to manage multiple studies and timelines efficiently
Commitment to safety, quality, and continuous improvement
Why Join Syngene
Syngene International Ltd. offers a world-class research environment where scientists contribute to cutting-edge biologics and biosimilar development. This role provides exposure to advanced bioanalytical technologies, global client collaborations, and opportunities to lead impactful scientific programs in a regulated environment.
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Manila |Croatia :
Croatia |Zagreb :
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