Director, Generics Drug Formulation （Solid Oral Products or Injectables）
Director of Genetics Formulation is responsible for formulation development, project management, and team development.
· Accountable for formulation development. Key activities include reviewing and revising development strategy and plans, evaluating research results, writing and approving submission documents, and solving key technical issues.
· Manage project progress, resource planning and allocation, and ensure compliance of document submission with CFDA filing regulations.
· Responsible for building development systems and establishing technology platforms.
· Evaluate external technologies, resources, and drug development opportunities for in-licensing.
· Responsible for building, managing, and training development teams.
· Master’s degree or higher in pharmaceutical sciences or related fields.
· A minimum of 10 years of industry experience in formulation and process development.
· Familiar with manufacturing processes and ability of trouble-shooting.
· Familiar with quality requirements of oral solid dosage forms, injectable formulation and process development, process validation and commercial production.
· Familiar with international technical requirements of drug product development (including ICH, US FDA and EMA and CFDA) and regulations of drug product applications.
· Knowledge of evaluation methods and requirements of formulation dosage forms, and ability to assess risks of BE studies and direct formulation development to improve the success rate of BE studies.
· Familiar with the development and production of scale equipment systems, including their working principles, capabilities, and quality requirements.
· Experience in team management, coaching and training of development teams.
· Good English and Mandarin (preferred) language skills.