Tasks

  • Lead and manage a team of up to three direct reports
  • Oversee a project portfolio comprising up to four small-scale projects
  • Organize laboratory activities in alignment with established guidelines and SOPs
  • Develop, optimize, and implement analytical methods for various applications
  • Lead the documentation and review of method development, validation, and implementation
  • Lead laboratory investigations to address product/process issues, deviations, CAPA, and complaints

Qualifications

  • Proven expertise in analytical method development, validation, and implementation (with a focus on HPLC)
  • Strong understanding of GMP, GLP, GDP, and regulatory requirements for drug development.
  • Excellent leadership, organizational, and communication skills.
  • Experience in managing cross-functional projects and collaborating with external partners.
  • Familiarity with regulatory submissions and health authority interactions.