Senior Pharmaceutical Development Manager

2 days ago

Melbourne, Victoria, Australia beBeeDevelopment Full time $120,000 - $180,000

About this Opportunity

We are seeking a seasoned Product Development Lead to spearhead pharmaceutical product development projects from concept to clinical execution.

You will support analytical and manufacturing activities, manage quality systems, and inform strategy to bring safe and effective new drugs to the clinic and market:

  • Contribute to strategic planning and resource allocation across drug development programs.
  • Provide timely feedback to senior stakeholders on project-related matters.
  • Support contract manufacturing operations 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 with vendors and licensees.
  • Manage Quality support, including maintenance of the Quality Management System (QMS).
  • Ensure suppliers meet necessary quality standards.

Qualifications and Skills

Tertiary qualifications in Chemistry, Pharmaceutical Science, or a related discipline.

Advanced degree qualifications in a relevant scientific field and/or business administration will be highly regarded.

5+ years of GMP experience in biotech or pharmaceutical settings.

Exceptional skills in project management and coordination of CDMOs and other partners.

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.

Familiarity with renal, respiratory, and other therapeutic areas, and their commercialization processes.

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