Site Head & Vice President, Manufacturing – Biotech

Role Overview

Apsida Life Science is partnered with a well-funded clinical-stage biotech company specializing in radiopharmaceuticals. We are looking for a Site Head & Vice President of Manufacturing to oversee the Australian GMP manufacturing facility and drive its advancement under TGA licensing. This executive-level role reports directly to the leadership team and commands full oversight of site operations, manufacturing output, and organizational efficiency as the company moves from clinical development toward commercial launch.

Key Responsibilities

• Lead strategic direction and accountability for all on-site manufacturing operations, ensuring activities are safe, compliant, and efficient.
• Formulate and implement operational strategies, goals, and performance metrics to support clinical progress, commercialization, and corporate growth targets.
• Manage cross-functional teams including Manufacturing, Manufacturing Sciences, Technical Services, Facilities Management, Supply Chain & Logistics, Radiation Safety, Health, Safety & Environment, along with other operational support units.
• Ensure dependable production and supply chain of Pb-212 radiopharmaceutical products to meet clinical trial needs, pipeline advancement, and commercial demands.
• Promote operational excellence via rigorous KPI oversight, continuous improvement efforts, resource optimization, and comprehensive risk management.
• Expand manufacturing capacity and infrastructure to accommodate pipeline growth, technology transfers, process scale-ups, and commercial-scale manufacturing.
• Direct clinical supply planning, production scheduling, isotope availability, inventory control, and distribution logistics to maintain uninterrupted product availability.
• Collaborate closely with Quality Assurance, Regulatory Affairs, Chemistry Manufacturing & Controls (CMC), Research & Development, Clinical, Engineering, and Infrastructure departments to align manufacturing activities with business objectives.
• Maintain compliance with current Good Manufacturing Practices (cGMP), TGA, FDA, PIC/S, ICH, and other regulatory standards, ensuring readiness for inspections at all times.
• Foster a organizational culture emphasizing safety, quality, accountability, and continual improvement.
• Build and mentor a high-caliber leadership team through coaching, succession planning, and talent development initiatives.
• Contribute to corporate strategy development, budgeting, forecasting, and long-term business planning.
• Serve as the primary site representative for regulatory inspections, customer audits, and stakeholder interactions.

Candidate Profile

The ideal candidate is a commercially astute and collaborative leader with extensive experience managing complex pharmaceutical manufacturing operations and guiding organizational growth through transition phases. They thrive in rapidly evolving environments and have a passion for team-building.

Essential Qualifications and Experience

• PhD, MSc, or equivalent degree in Engineering, Pharmaceutical Sciences, or related scientific discipline.
• Minimum five years of senior leadership experience in pharmaceutical manufacturing operations within a regulated environment, with a proven track record in cross-functional leadership.
• In-depth knowledge of cGMP standards and global regulatory frameworks including TGA, FDA, PIC/S, and ICH guidelines.
• Demonstrated success in scaling manufacturing operations from clinical development stages through to commercial readiness.
• Experience establishing new manufacturing facilities or operational models suitable for advancing clinical pipelines.
• Understanding of just-in-time manufacturing processes for short shelf-life pharmaceuticals.
• Strong capabilities in stakeholder management, communication, problem-solving, and influencing at all organizational levels.
• Genuine commitment to building an inclusive, collaborative, and high-performing work culture.

Why Join

This unique opportunity allows you to lead a cutting-edge manufacturing operation during an exciting phase of growth. You will directly impact corporate strategy and contribute toward delivering life-changing radiopharmaceutical therapies globally, while nurturing a world-class manufacturing team.