Job Opportunities API

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.         See Yourself at Telix To contribute to the achievement of the Group’s commercial and strategic goals by developing manufacturing and operational plans for the Group’s  commercial and late-stage  clinical assets in collaboration with  Regional Operations leadership , Supply Chain,  Program leadership,  and  the  Director s  of CMC Programs .   Ensuring their effective leadership, execution, and delivery; through the delivery of process development  and improvement  required for contract and regulatory compliance  as well as commercial  viability ; by ensuring adequate global production, supply chain, logistics and distribution planning to support current clinical development and commercial development of the Group’s assets .    This role  oversees subject matter experts in  Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging activities with  focus  on execution to company  objectives  with the level of quality needed per stage.   Key Accountabilities: Partner with contract manufacturers to ensure quality, deliveries and costs meet or exceed Telix’s expectations.   Provide oversight into the manufacturing, quality, and development of products from mid-stage clinical through commercial launch.   Partner with the Directors of CMC Programs to sustain, monitor, and improve both internal and external contract development/manufacturing organization (CDMO) strategies.   Partner with the Directors of CMC Programs to determine strategies for cost savings, supply redundancy, and process improvement within CDMO network.   Partner with Program leadership, Supply Chain, and the Directors of CMC Programs to develop manufacturing and capacity strategies consistent with the current and future marketing strategies (short and long term).   Manage complex technical issues to ensure efficient and effective business resolution.   Support quality investigations and non-conformances by providing appropriate product expertise.   Leadership, development, and performance management of the team of manufacturing engineers for the purpose of driving team capabilities to surpass company goals, including employing initiatives to coach employees to optimize their contribution and outputs.   Technical lead for business reviews with suppliers/contracting organizations.   Oversee technical transfers and process validation at internal and external CDMOs.   Education and Experience:   BA or BS degree in Engineering, Biology, Chemistry, or other relevant field   10+ years 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 Product/Substances supporting both clinical and commercial products