Study Director - Five Batch Analysis (Analytical Chemistry)

We are seeking a detail-oriented and skilled Analytical Scientist (Five Batch Analysis) with hands-on experience in conducting Phy-Chem and validation studies for agrochemicals and pharmaceutical compounds. The ideal candidate will have strong knowledge of global regulatory guidelines and be capable of preparing study-related documentation while maintaining audit readiness at all times.

Key Responsibilities:

• Conduct Physico-Chemical studies for agrochemical compounds in accordance with regulatory requirements.
• Act as Study Director for Five Batch Analysis studies in accordance with CRO and GLP regulatory requirements.
• Develop study plans, protocols, and schedules for analytical method validation and sample analysis.
• Review raw data, analytical reports, and ensure accurate documentation for regulatory submissions.
• Perform method validation studies for agrochemical products as per SANTEE/SANCO guidelines.
• Execute validation studies for pharmaceutical compounds as per ICH guidelines.
• Carry out dose formulation analysis to support toxicological and regulatory studies.
• Prepare and maintain Standard Operating Procedures (SOPs) for newly initiated studies.
• Develop study plans and compile final study reports as per relevant regulatory guidelines.
• Ensure all studies are conducted in compliance with GLP, OECD, OPPTS, CIPAC, SANCO, and SANTEE guidelines.
• Maintain effective communication with Quality Assurance (QA) personnel throughout the study lifecycle.
• Utilize Microsoft Excel for accurate calculations, data analysis, and result interpretation.
• Remain audit-ready at all times for sponsor audits, NGCMA inspections, or other regulatory reviews.

Key Skills:

Study Direction & GLP Compliance

Five Batch Analysis & Regulatory Submissions

Analytical Method Development & Validation

HPLC, UPLC, LC-MS/MS Expertise

Data Integrity & Quality Assurance

Client and Sponsor Interaction

Leadership & Team Mentoring

Qualifications & Experience:

Masters/PhD in Analytical Chemistry / Pharmaceutical Chemistry / Life Sciences or related discipline.

4-8 years of experience in Analytical R&D, QC, or CRO environment with exposure to GLP studies.

Hands-on experience with HPLC, UPLC, LC-MS/MS, and other advanced analytical techniques.

Prior experience as a Study Director for GLP studies, specifically Five Batch Analysis (mandatory).

Regards

NagaSravani G

nagasravani.g@virinchi.com