Product Development Lead

3 weeks ago

Melbourne, Victoria, Australia mexec Full time

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The Company
Our client is a growing ASX-listed biotechnology company leveraging cutting-edge proprietary technology in their innovative approach to drug development. They have a portfolio of candidates which includes novel compounds and repurposed drugs and programs ranging from pre-clinical through to clinical-stage development. Their lead candidate is currently in Phase III trials and has generated significant interest from investors and clinicians globally.

The Opportunity
As the Product Development Lead, you will play a pivotal role in driving pharmaceutical product development projects from concept to clinical execution. You will support analytical and manufacturing activities, manage quality systems, and inform strategy to help bring safe and effective new drugs to the clinic and to market:

  • 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.
The 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.
The Offer
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 appoint may be higher for an experienced candidate who is an excellent fit. Please email questions and expressions of interest to careers@mexec.com or call 1300 063 932. To apply, please visit www.mexec.com and click Apply Now to submit a copy of your current CV and cover letter.Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionScience

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