Director, Manufacturing Operations

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Develop manufacturing and operational plans for commercial and late-stage clinical assets in collaboration with Regional Operations, Supply Chain, Program leadership, and Directors of CMC Programs • Ensure effective leadership, execution, and delivery of process development and improvement for contract and regulatory compliance and commercial viability • Ensure global production, supply chain, logistics, and distribution planning supports clinical and commercial development • Oversee subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging • Partner with contract manufacturers to ensure quality, deliveries, and costs meet or exceed expectations • Provide oversight of manufacturing, quality, and product development from mid-stage clinical through commercial launch • Sustain, monitor, and improve internal and external CDMO strategies • Determine strategies for cost savings, supply redundancy, and process improvement within the CDMO network • Develop short- and long-term manufacturing and capacity strategies aligned with marketing strategies • Manage complex technical issues for efficient business resolution • Support quality investigations and non-conformances with product expertise • Lead, develop, and manage the performance of the manufacturing engineering team • Serve as technical lead for business reviews with suppliers and contracting organizations • Oversee technical transfers and process validation at internal and external CDMOs

🎯 Requirements

• BA or BS degree in Engineering, Biology, Chemistry, or another relevant field • 10+ years of combined experience in late-stage clinical to commercial cGMP manufacturing, engineering, contract manufacturing, and/or quality • 3+ years of previous management experience • Direct experience in sterile injectable filling and lyophilization of drug products/substances supporting clinical and commercial products • Experience working with international contract manufacturing organizations • Ability to travel approximately 30% domestically and internationally • Direct experience in secondary packaging of parenteral drugs preferred • Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred • Commitment to excellence, results orientation, creativity and innovation, strong communication, collaboration, resilience, inclusivity, adaptability, ethical behavior, and continuous learning

🏖️ Benefits

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development