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 Global Manufacturing Engineer provides technical expertise for process development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics, ensuring processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for serving as the technical lead on internal cross-functional teams and with external CDMO partners, collaborating with all stakeholders to develop and execute clinical and commercial manufacturing.

Key Accountabilities: Technical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics. Analyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies.

Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analysis. Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestones.

Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products. Author and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filings Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system. , Excel, Word, Project) Experience working with cross-functional teams, external partners and CDMOs Experience in authoring challenging technical documents, including but not limited to, protocols, reports, CMC modules, and filing response.

Strong experience in a key functional area within pharmaceutical operations Experience in pharmaceutical and process development Key Capabilities: Autonomy: Comfortable working independently with senior-level support Strong communication skills: Able to communicate effectively with internal and external colleagues and stakeholders, using clear and concise language.