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Study Director

2 weeks ago

Hyderabad, Telangana, India Vivo Bio Tech Ltd Full time US$ 90,000 - US$ 1,20,000 per year

Job Description:

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