Sustainability Engineer
Telix Pharmaceuticals Limited
June 27, 2026
On-site
United States
Corporate Functions
This role provides technical support and training for radiopharmaceutical preparation, participates in validation activities and CDMO qualification initiatives, and supports technical transfers, troubleshooting, and continuous improvement. Provides leadership and technical expertise to cross-functional teams and supports field execution with a focus on compliance with industry regulations, quality standards, and regulatory frameworks. Provides first line technical support for ongoing batch manufacturing.
Key Accountabilities
- Technical lead of tech transfer and manufacturing activities related to drug substance/drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals
- Analyze production processes; identify/communicate gaps, risks, and inefficiencies; drive process improvements and risk mitigations; lead manufacturing investigations and root cause analyses
- Support implementation of cold and hot analytical methods under internal QC SMEs
- Support Regulatory Affairs for IND and new NDA submissions; inspection readiness; participate in regulatory inspections; provide audit support
- Manage technical collaborations with multiple CDMOs to meet key milestones
- Author/review SOPs, batch records, protocols, and reports for clinical/commercial products
- Ensure compliance via document creation/review/approval, quality investigations, corrective actions, and change control
- Follow procedures to support intellectual property protection
- First point of contact for technical questions/escalations for ongoing batch manufacturing
- Work with Quality Assurance to support manufacturing partners
Education And Experience
- Bachelor’s/Master’s in science/engineering with >7 years radiopharmaceutical (incl. GMP) OR PhD with >5 years (incl. GMP)
- PET manufacturing, automated synthesis modules, analytical experience desirable
- Hands-on experience with isotopes (e.g., F-18, Lu-177, I-131) plus
- Demonstrated leadership/managerial skills
- Cross-functional and CDMO management experience ensuring cGMPs/timelines
- Radiation safety principles (ALARA) and regulatory requirements knowledge
- MS Office (Excel, Word, Project)
- Experience authoring technical documents (protocols, reports, SOPs, quality investigations)
- Experience in radiopharmaceutical and process development
Travel expectation: ~10–25%.
Key Accountabilities
- Technical lead of tech transfer and manufacturing activities related to drug substance/drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals
- Analyze production processes; identify/communicate gaps, risks, and inefficiencies; drive process improvements and risk mitigations; lead manufacturing investigations and root cause analyses
- Support implementation of cold and hot analytical methods under internal QC SMEs
- Support Regulatory Affairs for IND and new NDA submissions; inspection readiness; participate in regulatory inspections; provide audit support
- Manage technical collaborations with multiple CDMOs to meet key milestones
- Author/review SOPs, batch records, protocols, and reports for clinical/commercial products
- Ensure compliance via document creation/review/approval, quality investigations, corrective actions, and change control
- Follow procedures to support intellectual property protection
- First point of contact for technical questions/escalations for ongoing batch manufacturing
- Work with Quality Assurance to support manufacturing partners
Education And Experience
- Bachelor’s/Master’s in science/engineering with >7 years radiopharmaceutical (incl. GMP) OR PhD with >5 years (incl. GMP)
- PET manufacturing, automated synthesis modules, analytical experience desirable
- Hands-on experience with isotopes (e.g., F-18, Lu-177, I-131) plus
- Demonstrated leadership/managerial skills
- Cross-functional and CDMO management experience ensuring cGMPs/timelines
- Radiation safety principles (ALARA) and regulatory requirements knowledge
- MS Office (Excel, Word, Project)
- Experience authoring technical documents (protocols, reports, SOPs, quality investigations)
- Experience in radiopharmaceutical and process development
Travel expectation: ~10–25%.