20 Aug
|
Apsida Life Science
|
Queensland
20 Aug
Apsida Life Science
Queensland
Job Description
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.
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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.
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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.
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Key Responsibilities
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Provide strategic leadership and accountability for all site operations, ensuring safe, compliant, and efficient manufacturing activities.
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Develop and execute the site's operational strategy, objectives, and performance plans to support clinical development, commercialisation, and corporate growth.
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Lead multidisciplinary functions including Manufacturing, Manufacturing Sciences, Technical Services, Facilities, Supply Chain & Logistics, Radiation Safety, Health, Safety & Environment (HSE), and other operational support teams.
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Ensure the reliable manufacture and supply of Pb-212
radiopharmaceutical
products to support clinical trials, pipeline advancement, and future commercial demand.
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Drive operational excellence through KPI management, continuous improvement initiatives,
resource optimisation, and risk management.
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Develop manufacturing capacity and infrastructure to support pipeline expansion, technology transfer, process scale-up, and commercial manufacturing.
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Oversee clinical supply planning, production scheduling, isotope availability, inventory management, and distribution logistics to ensure uninterrupted product supply.
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Collaborate closely with Quality, Regulatory Affairs, CMC, R&D;, Clinical, Engineering, and Infrastructure teams to deliver manufacturing strategies aligned with business objectives.
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Maintain compliance with cGMP, TGA, FDA, PIC/S, ICH, and other applicable regulatory requirements while ensuring ongoing inspection readiness.
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Champion a culture of safety, quality, accountability, and continuous improvement across the organisation.
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Build, mentor, and develop a high-performing leadership team through coaching, succession planning, and talent development.
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Contribute to corporate strategy, budgeting, forecasting, and long-term business planning.
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Act as the senior site representative during regulatory inspections, customer audits, and key stakeholder engagements.
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About You
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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.
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PhD, MSc, or equivalent qualification in Engineering, Pharmaceutical Sciences, or a related scientific discipline.
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Proven leadership experience within pharmaceutical manufacturing, including at least five years in senior cross-functional operational leadership roles.
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Experience leading GMP manufacturing operations within a highly regulated pharmaceutical or biotechnology environment.
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Strong understanding of cGMP requirements and global regulatory frameworks, including TGA, FDA, PIC/S, and ICH guidelines.
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Demonstrated success scaling manufacturing operations from clinical development through commercial readiness.
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Experience establishing new manufacturing sites or implementing phase-appropriate operational models to support pipeline progression.
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Knowledge of just-in-time manufacturing and supply of short shelf-life medicines.
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Excellent leadership, stakeholder management, communication, and problem-solving skills, with the ability to influence across all levels of the organisation.
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A genuine commitment to fostering an inclusive, collaborative, and high-performing culture.
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Why Join Us?
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This is a rare opportunity to join an cutting-edge 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.
#J-*****-Ljbffr
📌 Site Head & Vice President, Manufacturing - Biotech (Queensland)
🏢 Apsida Life Science
📍 Queensland