Pharmaceutical Product Development Manager
7 days ago
The Product Development Manager is accountable for the success of our pharmaceutical product development projects.
- This includes overseeing analytical and manufacturing activities, managing quality systems, and driving strategy to help bring safe and effective new drugs to market.
The key responsibilities of this role include:
- Contribute to strategic planning and resource allocation across drug development programs.
- Provide timely feedback to stakeholders 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 partners.
- Manage Quality support, including maintenance of the Quality Management System (QMS).
- Ensure new and existing suppliers meet necessary quality standards.
To be successful in this role, you will require:
- 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.
This is an exciting opportunity to join a talented team of experts and make a significant contribution to the development of innovative new drugs.
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