Study Director – Pharmacokinetics & Immunogenicity Assays | Bengaluru, India
Company: Syngene International Limited | Location: Bengaluru, Karnataka, India | Job Type: Full-Time | Experience Level: Experienced
About Syngene
Founded in 1993, Syngene International Ltd. is a globally recognized discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Syngene partners with global leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife, delivering solutions that improve R&D productivity, accelerate time-to-market, and reduce innovation costs. The company’s 4,240-strong team of scientists fosters a culture of innovation, collaboration, and scientific excellence.
Role Overview
Syngene is seeking an experienced Study Director – Pharmacokinetics and Immunogenicity Assays to lead bioanalytical activities in the GLP-compliant laboratory. The role involves ligand binding assay (LBA) development, validation, and sample analysis, focusing on pharmacokinetic and immunogenicity studies. The Study Director will ensure regulatory compliance, data integrity, and timely execution of projects while providing scientific oversight and technical guidance.
This position offers hands-on experience in advanced immunoassays, strategic project planning, data interpretation, and presentation for both internal teams and offshore clients.
Key Responsibilities
Execute bioanalytical assays in compliance with SOPs, regulatory guidance, and GxP standards.
Develop, validate, and analyze Ligand Binding Assays (LBA); expertise in ELISA and MSD assays is highly desirable.
Collaborate with Study Director, QC, and QA for data review, closure of observations, and archival.
Prepare reagents, buffers, and maintain lab documentation and logbooks for all assigned assays.
Interpret and present study data, identifying issues proactively and recommending solutions.
Contribute to SOP, protocol, method, and report preparation.
Ensure adherence to environment, health, and safety (EHS) standards within the laboratory.
Support strategic planning for project execution, including documentation, data analysis, and result interpretation.
Required Experience & Qualifications
Education: Master’s degree in Biological Sciences, preferably Biochemistry, or a related field.
Experience: Hands-on experience in bioanalytical pharmacokinetics and immunogenicity assays, including LBA development, validation, and sample analysis.
Familiarity with regulatory guidelines such as OECD, GxP, 21 CFR Part 11, EMA, and FDA.
Knowledge of laboratory software: LIMS, GraphPad, Adobe, or equivalent.
Experience in manuscript writing is a plus.
Skills & Competencies
Ability to work independently and collaboratively in a multidisciplinary team.
Proactive problem-solving and independent thinking.
Strong written and oral communication skills in English.
Flexibility to work under tight deadlines and project pressures.
Attention to detail and commitment to data integrity, quality, and compliance.
Equal Opportunity Employer
Syngene is committed to providing equal employment opportunities (EEO) to all applicants without regard to age, race, color, gender, religion, national origin, disability, veteran status, or any legally protected characteristic. Reasonable accommodations are provided 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 bioanalysis.
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