Study Director – Pharmacokinetics & Immunogenicity Assays
Location: Bangalore, Karnataka, India
Experience Required: Master’s degree with relevant bioanalytical experience, preferably in ligand binding assays
Division: Discovery Services – Translational and Clinical Research
Company: Syngene International Ltd.
About Syngene:
Founded in 1993, Syngene International Ltd. is a global leader in discovery, development, and manufacturing, providing integrated scientific solutions across pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Our clientele includes world-renowned organizations such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Syngene’s 4,240-strong team of scientists drives innovation, improves R&D productivity, accelerates time-to-market, and lowers the cost of drug development.
Role Overview:
The Study Director – Pharmacokinetics & Immunogenicity Assays will lead bioanalytical studies, including ligand binding assays, for pharmacokinetic (PK) and immunogenicity analyses. This role is critical for ensuring regulatory-compliant, high-quality data generation, interpretation, and reporting in alignment with global standards. The position offers the opportunity to actively participate in strategic planning, assay development, and cross-functional collaboration with QC, QA, and project teams.
Key Responsibilities:
Oversee bioanalytical laboratory activities in compliance with SOPs, regulatory guidelines, and internal quality systems.
Lead development, validation, and execution of ligand binding assays (LBA), ELISA, and MSD assays for PK and immunogenicity studies.
Plan and execute project strategies, including data documentation, analysis, interpretation, and presentation.
Prepare and maintain reagents, buffers, and assay logbooks.
Actively contribute to drafting SOPs, protocols, technical reports, and study documentation.
Collaborate with Study Directors, QC, and QA teams for raw data review, closure of observations, and archival.
Present analytical results in internal meetings, offering scientific insight and troubleshooting assay-related issues.
Ensure strict adherence to environment, health, and safety (EHS) protocols.
Educational & Experience Requirements:
Master’s degree in Biological Sciences, preferably Biochemistry, or a related field.
Strong hands-on experience in immunoassays, bioanalytical PK, and immunogenicity assays.
Expertise in ligand binding assay development, validation, and sample analysis.
Familiarity with regulatory standards, including OECD, GxP, 21 CFR Part 11, EMA, and FDA guidelines.
Experience with software tools such as LIMS, GraphPad, and Adobe Suite is preferred.
Manuscript writing and scientific reporting experience is an advantage.
Behavioral Skills:
Strong proactive and independent thinker with excellent problem-solving skills.
Effective communication skills (written and oral English) with strong interpersonal abilities.
Ability to work under pressure and adapt to dynamic project timelines.
Collaborative mindset to work effectively within cross-functional teams.
Why Join Syngene:
Opportunity to work in a highly innovative, globally recognized research environment.
Exposure to cutting-edge translational and clinical research in pharmacokinetics and immunogenicity.
Engage with a collaborative team, drive high-impact projects, and contribute to scientific advancement in drug development.
Equal Opportunity Employer:
Syngene is committed to equal employment opportunity and provides reasonable accommodations for qualified individuals with disabilities. Applications are encouraged from all qualified candidates regardless of age, gender, race, religion, disability, or other legally protected characteristics.
Application Instructions:
Submit your CV and cover letter highlighting relevant bioanalytical experience and motivation for the role via the Syngene careers portal.
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