Senior Biotechnology Drug Development Leader
As a key member of the biotechnology team, you will contribute to strategic planning and resource allocation across various drug development programs. This role requires strong project management skills, excellent communication, and the ability to collaborate with vendors and internal stakeholders.
Key Responsibilities
* Strategically plan and execute biotechnology projects from pre-clinical through to clinical-stage development.
* Develop and implement quality control procedures to ensure regulatory compliance.
* Oversee tech transfer, formulation, and method development and validation studies.
* Manage Quality support, including maintenance of the Quality Management System (QMS).
* Ensure new and existing suppliers meet necessary quality standards.
Requirements
* Tertiary qualifications in Chemistry or Pharmaceutical Science.
* Higher Degree qualifications in a relevant scientific field will be highly regarded.
* 5+ years of GMP experience in biotech or pharmaceutical settings.
* Excellent skills in project management, coordination of CDMOs, and other vendors.
* Comprehensive understanding of the regulatory, scientific, medical and commercial aspects of drug development and approval in local and international markets.
* Knowledge of renal, respiratory, and other therapeutic areas, and their commercialisation processes.