Lead Pharmaceutical Product Development
As a key member of the drug development team, you will be responsible for driving pharmaceutical product development projects from concept to clinical execution. This involves managing quality systems, analytical and manufacturing activities, and informing 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 executive leaders on project-related matters.
* Support 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
To be successful in this role, you must have:
* 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.
* At least 5 years of experience in GMP environments, preferably 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.
This is an exciting opportunity to join a talented team and contribute to the development of innovative new drugs.
Key Responsibilities
The successful candidate will be responsible for:
* Developing and implementing strategies to drive drug development projects forward.
* Managing quality systems and ensuring compliance with regulatory requirements.
* Coordinating with vendors and licensees to ensure smooth project execution.
* Providing timely feedback to executive leaders and stakeholders.
We are looking for a highly skilled and experienced professional to join our team. If you have a passion for drug development and a strong track record of delivering results, we encourage you to apply.