Director, Manufacturing Operations

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.

- 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.

- 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

- Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both clinical and commercial products

- Direct experience in Secondary Packaging of Parenteral drugs preferred

- Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred

- Experience working with International Contract Manufacturing Organizations

- Ability to travel approximately 30% - both domestically and internationally