Study Director

Drlogy; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Drlogy in Vadodara, Gujarat is hiring a Study Director – Dose Formulation Analysis to lead analytical studies focusing on dose formulation concentration, homogeneity, and stability. You will manage study protocols, coordinate with various teams, and ensure compliance with GLP and regulatory standards.

The ideal candidate will possess expertise in analytical chemistry and method application along with strong data interpretation skills. This role involves significant interaction with project teams to support compliant and scientifically sound analysis.

Qualifications

• Expertise in analytical chemistry and method application.
• Experience in study planning and data interpretation.
• Knowledge of GLP-compliant documentation practices.

Responsibilities

• Plan and manage dose formulation analysis studies as per protocols.
• Review study requirements related to concentration and stability.
• Coordinate analytical testing of dose formulations with teams.
• Ensure compliance with GLP, SOPs, and regulatory expectations.
• Interpret analytical findings and coordinate with relevant teams.

Skills

Analytical chemistry

Method application

Data interpretation

GLP-compliant documentation

Job description

The Study Director – Dose Formulation Analysis will lead and manage analytical studies related to dose formulation concentration, homogeneity, stability, and verification. This requires expertise in analytical chemistry, method application, study planning, data interpretation, and GLP-compliant documentation. The candidate will coordinate with toxicology, formulation, analytical, QA, and project teams to ensure scientifically sound and regulatory-compliant dose formulation analysis studies.

Responsibilities

• Plan and manage dose formulation analysis studies as per approved protocols and timelines.
• Review study requirements related to concentration, homogeneity, and stability analysis.
• Coordinate analytical testing of dose formulations with laboratory and study teams.
• Prepare or review study protocols, analytical plans, amendments, and final reports.
• Ensure all study activities comply with GLP, SOPs, and regulatory expectations.
• Review chromatographic data, calculations, raw data, and analytical results for accuracy.
• Interpret analytical findings and confirm suitability of dose formulations for study use.
• Coordinate with toxicology, formulation, QA, and bioanalytical teams for study execution.
• Monitor sample receipt, labeling, storage, preparation, and analysis timelines.
• Investigate deviations, abnormal results, and out-of-specification observations.
• Ensure complete documentation of raw data, worksheets, instrument records, and reports.
• Support method verification, method transfer, and analytical troubleshooting when required.
• Respond to QA observations and ensure timely closure of study-related findings.
• Train junior personnel on dose formulation analysis procedures and compliance practices.
• Maintain data integrity, scientific accuracy, and confidentiality throughout the study lifecycle.