Job Title: Principal Scientist – Immunogenicity Research Laboratory
Company: Syngene International Ltd.
Location: Bangalore, Karnataka, India
Division: Discovery Services
Department: Translational and Clinical Research
Employment Type: Full-time
Experience Required: 8+ years of experience in Immunoassay/Bioanalytical Research with strong expertise in Pharmacokinetics (PK), Immunogenicity assays, and Ligand Binding Assay (LBA) development (CRO experience preferred).
Education: Master’s degree in Biological Sciences, Biochemistry, Biotechnology, Life Sciences, or a related field.
Salary Package: ₹18–30 LPA (Estimated as per current market standards for Principal Scientist roles in Bioanalytical/Immunogenicity Research in India; final compensation depends on experience, technical expertise, and interview performance.)
Job Purpose:
Lead bioanalytical activities focused on Pharmacokinetics and Immunogenicity studies by performing ligand binding assays, data analysis, interpretation, and ensuring regulatory-compliant laboratory operations.
Key Responsibilities:
Perform bioanalysis activities including Pharmacokinetic and Immunogenicity assays.
Develop, optimize, validate, and analyze Ligand Binding Assays (LBA).
Conduct immunoassays such as:
ELISA
MSD assays
Other ligand-binding platforms
Ensure laboratory activities comply with:
SOPs
Regulatory guidelines
Quality systems
Internal procedures
Collaborate with:
Study Directors
Quality Control (QC)
Quality Assurance (QA) teams
Support raw data review, report review, observation closure, and archival activities.
Plan and execute project strategies, timelines, and deliverables.
Analyze, interpret, and present scientific data.
Prepare:
SOPs
Study protocols
Analytical methods
Scientific reports
Prepare reagents, buffers, and maintain assay documentation/logbooks.
Troubleshoot assay-related challenges and provide scientific solutions.
Participate in scientific discussions and data presentations.
Ensure compliance with Environmental Health & Safety (EHS) requirements.
Support training and knowledge-sharing activities.
Required Technical Skills:
Immunogenicity Assays
Bioanalytical Method Development
Ligand Binding Assay (LBA)
Assay Validation
Sample Analysis
Pharmacokinetics (PK) Bioanalysis
ELISA
MSD Assays
Immunoassay Troubleshooting
Regulatory Compliance
Data Analysis & Interpretation
Scientific Documentation
SOP and Protocol Writing
Regulatory Knowledge:
OECD Guidelines
GxP Compliance
21 CFR Part 11
FDA Guidelines
EMA Guidelines
Bioanalytical Regulatory Practices
Software Skills:
Laboratory Information Management System (LIMS)
GraphPad Prism
Adobe Tools
Scientific Data Management Systems
Preferred Skills:
Experience in CRO-based bioanalytical laboratories.
Experience supporting regulated studies.
Manuscript writing and scientific publication experience.
Strong understanding of industry standards for immunogenicity testing.
Ability to lead projects and mentor team members.
Behavioral Skills:
Strong scientific problem-solving ability.
Independent decision-making capability.
Excellent written and verbal communication skills.
Strong interpersonal and collaboration skills.
Ability to manage multiple priorities under strict timelines.
Flexible and proactive approach.
Work Location: Bangalore, India
Benefits:
Opportunity to work on global pharmaceutical and biotechnology research programs.
Exposure to translational research and drug development.
Career growth opportunities in scientific leadership.
Collaborative research environment.
Opportunity to contribute to innovative healthcare solutions.
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