Director, Manufacturing Operations

Telix Pharmaceuticals (AMER)

5d•Hybrid

About The Position

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 Directors 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.

Requirements

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
Experience working with International Contract Manufacturing Organizations
Ability to travel approximately 30% - both domestically and internationally

Nice To Haves

Direct experience in Secondary Packaging of Parenteral drugs preferred
Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred

Responsibilities

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.