Study Director

Role & responsibilities

• Working with a collaborative Bioanalytical team on large molecule analysis for established assays and working on novel analytical platforms and ideas for PK/TK, PD (Biomarkers), ADA and Nab (Cell based and non-cell based).
• Ensure regulatory compliance across all bioanalytical programs, adhering to GLP & GCLP standards for method development, transfer, validation, and sample analysis for biologics.
• Ensure the technical compliance of programs by adhering to latest guidelines and white papers, maintaining high-quality deliverables and adherence to project timelines.
• Independently manage studies and team, from executing studies to technical data review, analysis, and interpretation using advanced software tools.
• Engage in technical forecasting, troubleshooting, client interactions, and strategic planning to ensure the successful execution of programs.
• Work collaboratively across various functions within the laboratory and departments within Syngene - BD, Quality, Logistics, etc

Preferred candidate profile

• Minimum of 5 years of direct experience in large molecule bioanalysis, with a strong focus on ligand binding assays, biological assays, and cell-based assays.
• Demonstrated success in regulatory audits and dossier submissions related to bioanalytical studies.
• Experience in a GLP/GCLP bioanalytical laboratory.

Perks and benefits