Tasks

  • Oversee development and production of drug substances (API)
  • Lead technical development and commercial manufacturing activities for drug substances and products
  • Develop and implement CMC/Product Team strategies
  • Manage technical activities for API development, scale-up, and manufacturing from preclinical to late-stage clinical development
  • Collaborate with Global Supply Chain, Discovery Chemistry, and Project Management teams
  • Ensure strategy implementation within the Life Cycle Team and with third parties

Qualifications

  • Education: PhD in Chemistry or Chemical Engineering
  • Minimum 7 years in the pharmaceutical or chemical industry
  • At least 2 years in leading cross-functional teams in pharmaceutical development or commercial projects
  • Strong knowledge of drug substance (API) development and manufacturing
  • Familiarity with GMP, quality control, and pharmaceutical regulations
  • Experience with API development from Phase 1 to commercial stages
  • Proficient in QbD, process validation, and registration
  • Excellent understanding of the pharmaceutical custom manufacturing market
  • Proficient in English (oral and written)