Apsida are currently partnered with a well funded clinical stage biotech in the radiopharmaceutical industry. We are seeking an Site Head & Vice President, Manufacturing to lead our Australian GMP manufacturing facility and play a pivotal role in advancing the Australian TGA-licensed GMP radiopharmaceutical manufacturing facility.
Reporting into the executive leadership team, you will have overall responsibility for site operations, manufacturing performance, and organisational effectiveness. This is a unique opportunity to lead a growing biotech as it transitions from clinical-stage development through commercial readiness.
The successful candidate will be an inspirational leader with a strong track record of building high-performing teams, driving operational excellence, and delivering compliant pharmaceutical manufacturing within a highly regulated environment.
Key Responsibilities
- Provide strategic leadership and accountability for all site operations, ensuring safe, compliant, and efficient manufacturing activities.
- Develop and execute the site's operational strategy, objectives, and performance plans to support clinical development, commercialisation, and corporate growth.
- Lead multidisciplinary functions including Manufacturing, Manufacturing Sciences, Technical Services, Facilities, Supply Chain & Logistics, Radiation Safety, Health, Safety & Environment (HSE), and other operational support teams.
- Ensure the reliable manufacture and supply of Pb-212 radiopharmaceutical products to support clinical trials, pipeline advancement, and future commercial demand.
- Drive operational excellence through KPI management, continuous improvement initiatives, resource optimisation, and risk management.
- Develop manufacturing capacity and infrastructure to support pipeline expansion, technology transfer, process scale-up, and commercial manufacturing.
- Oversee clinical supply planning, production scheduling, isotope availability, inventory management, and distribution logistics to ensure uninterrupted product supply.
- Collaborate closely with Quality, Regulatory Affairs, CMC, R&D, Clinical, Engineering, and Infrastructure teams to deliver manufacturing strategies aligned with business objectives.
- Maintain compliance with cGMP, TGA, FDA, PIC/S, ICH, and other applicable regulatory requirements while ensuring ongoing inspection readiness.
- Champion a culture of safety, quality, accountability, and continuous improvement across the organisation.
- Build, mentor, and develop a high-performing leadership team through coaching, succession planning, and talent development.
- Contribute to corporate strategy, budgeting, forecasting, and long-term business planning.
- Act as the senior site representative during regulatory inspections, customer audits, and key stakeholder engagements.
About You
You are a collaborative and commercially minded manufacturing leader with experience leading complex pharmaceutical operations and developing organisations through periods of growth. You thrive in fast-paced, innovative environments and enjoy building teams.
- PhD, MSc, or equivalent qualification in Engineering, Pharmaceutical Sciences, or a related scientific discipline.
- Proven leadership experience within pharmaceutical manufacturing, including at least five years in senior cross-functional operational leadership roles.
- Experience leading GMP manufacturing operations within a highly regulated pharmaceutical or biotechnology environment.
- Strong understanding of cGMP requirements and global regulatory frameworks, including TGA, FDA, PIC/S, and ICH guidelines.
- Demonstrated success scaling manufacturing operations from clinical development through commercial readiness.
- Experience establishing new manufacturing sites or implementing phase-appropriate operational models to support pipeline progression.
- Knowledge of just-in-time manufacturing and supply of short shelf-life medicines.
- Excellent leadership, stakeholder management, communication, and problem-solving skills, with the ability to influence across all levels of the organisation.
- A genuine commitment to fostering an inclusive, collaborative, and high-performing culture.
Why Join Us?
This is a rare opportunity to join an innovative organisation at a transformative stage of growth. You will lead a state-of-the-art manufacturing operation, influence company strategy, and help bring life-changing radiopharmaceutical therapies to patients worldwide while building a world-class manufacturing organisation.
