Study Director – Pharmacokinetics & Immunogenicity Assays | Bengaluru, India
Company: Syngene International Limited
Location: Bengaluru, Karnataka, India
Division: Discovery Services
Department: Translational and Clinical Research
Experience Level: Experienced | Job Type: Full-Time
About Syngene
Established in 1993, Syngene International Ltd. is a global, innovation-driven organization providing discovery, development, and manufacturing solutions across pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. Syngene partners with leading global companies including Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife, delivering high-quality scientific services that accelerate R&D, reduce costs, and shorten time-to-market. The organization’s 4,240-strong team fosters a culture of innovation, collaboration, and scientific excellence.
Role Overview
Syngene is seeking a highly skilled Study Director – Pharmacokinetics and Immunogenicity Assays to lead bioanalytical studies in a GLP-compliant laboratory. The Study Director will oversee ligand binding assay (LBA) development, validation, and sample analysis, ensuring compliance with regulatory standards, SOPs, and GxP guidelines. This role requires hands-on expertise, strategic oversight, and collaboration with QC, QA, and offshore client teams.
The position offers exposure to advanced immunoassays, pharmacokinetic studies, and immunogenicity assessments, while fostering skills in data interpretation, project execution, and scientific reporting.
Key Responsibilities
Execute bioanalytical assays in compliance with SOPs, GxP standards, and regulatory guidelines.
Conduct LBA development, validation, and sample analysis; experience with ELISA and MSD assays is highly desirable.
Collaborate with Study Director, QC, and QA for raw data review, observation closure, and archival.
Prepare reagents, buffers, and maintain logbooks for all assays.
Analyze and interpret study data, anticipate assay-related challenges, and provide solutions.
Contribute to protocols, SOPs, method documentation, and scientific reports.
Participate in scientific discussions and present study results effectively.
Ensure environment, health, and safety (EHS) compliance in the laboratory at all times.
Support strategic planning, project execution, and documentation management.
Required Qualifications & Experience
Education: Master’s degree in Biological Sciences (Biochemistry preferred) or related field.
Experience: Proven experience in immunoassays, pharmacokinetics, and immunogenicity bioanalysis.
Hands-on experience in LBA development, validation, and sample analysis.
Knowledge of regulatory requirements including OECD, GxP, 21 CFR Part 11, EMA, FDA guidelines.
Proficiency in laboratory software: LIMS, GraphPad, Adobe.
Manuscript writing skills are a plus.
Behavioral Competencies
Strong independent and collaborative working skills.
Proactive problem-solving and critical thinking abilities.
Excellent written and oral communication skills in English.
Flexibility and ability to work under tight deadlines.
Strong interpersonal skills and team orientation.
Equal Opportunity Employer
Syngene provides equal employment opportunities (EEO) to all applicants regardless of age, race, color, gender, religion, disability, veteran status, sexual orientation, or any legally protected characteristic. Reasonable accommodations are available for qualified individuals with disabilities.
Apply Now to join Syngene’s Translational and Clinical Research team in Bengaluru and contribute to cutting-edge pharmacokinetics and immunogenicity bioanalytical research.
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Siliguri |Illinois :
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