Drug Development Project Manager

7 days ago


Melbourne, Victoria, Australia beBeeDevelopment Full time $180,000 - $220,000
Product Development Lead Job Overview

As the Product Development Lead, you will play a pivotal role in driving pharmaceutical product development projects from concept to clinical execution.

Key Responsibilities:
  • Contribute to strategic planning and resource allocation across drug development programs.
  • Provide timely feedback to stakeholders on project-related matters.
  • Support contract development and manufacturing organization (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 partners.
  • 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.
  • Knowledge of renal, respiratory, and other therapeutic areas, and their commercialisation processes.
About This Opportunity

This is a rare opportunity to join an innovative team of experts and make a significant contribution to the development of exciting new drugs.

The level and title of this appointment may be higher for an experienced candidate who is an excellent fit.


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