Group Leader – API – Analytical Development

22 hours ago

Baddi, Himachal Pradesh, India Morepen Proprietary Drug Research Pvt Ltd Full time

Role Description

This is a full-time, on-site role located in Baddi for a Group Leader – API – Analytical Development. The Group Leader will oversee and lead analytical development projects, ensuring compliance with quality and regulatory standards. Daily responsibilities include managing analytical method development, validation, and transfer processes, as well as troubleshooting analytical challenges. This role also involves team management, collaborating with cross-functional departments, and contributing to the preparation of technical documents for regulatory submissions.

Qualifications

  • Strong knowledge of Analytical Method Development, Validation, and Method Transfer processes, DMF filings support
  • Experience with High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and related instrumental techniques
  • Familiarity with regulatory guidelines (e.g., ICH, US FDA, EU) and industry standards
  • Proficiency in troubleshooting analytical instruments and processes
  • Project management and team leadership abilities in a scientific or R&D setting
  • Exceptional problem-solving skills, attention to detail, and analytical thinking
  • Master's or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline
  • Previous experience in API or pharmaceutical analytical research and development

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