Senior Pharmaceutical Project Manager

1 week ago

Melbourne, Victoria, Australia beBeeDevelopment Full time $150,000 - $200,000
Product Development Lead Role

The role of Product Development Lead is pivotal in driving pharmaceutical product development projects from concept to clinical execution. This position requires a skilled professional to oversee the development of safe and effective new drugs.

This involves strategic planning, resource allocation, and timely feedback to the Executive Leadership Team on project-related matters.

Key Responsibilities:
  • Contribute to strategic planning and resource allocation across drug development programs.
  • Provide timely feedback to the Executive Leadership Team on project-related matters.
  • Support CDMO production to ensure ongoing supply for clinical and development activities.
  • Oversee projects in tech transfer, formulation, and method development and validation studies.
  • Review and evaluate stability protocols, reports, and trend data to maintain regulatory compliance.
  • Participate in internal and external project meetings, including with vendors and licensees.
  • 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, Pharmaceutical Science, or a related discipline.
  • Higher Degree qualifications in a relevant scientific field and/or MBA will be highly regarded.
  • 5+ years of GMP experience in biotech or pharmaceutical settings.
  • Excellent skills in project management and coordination of CDMOs and other vendors.
  • Experience managing CMC and quality activities, clinical trial supply, and analytical studies.
  • Comprehensive understanding of the regulatory, scientific, medical and commercial aspects of drug development and approval in key local and international markets, including the US and Europe.
  • Knowledge of renal, respiratory, and other therapeutic areas, and their commercialisation processes.

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