Sustainability Engineer
Telix Pharmaceuticals Limited
August 09, 2026
Remote friendly (United States)
United States
Other
Key Accountabilities:
- Technical lead of tech transfer and manufacturing activities for drug substance/drug product formulation, radiolabeling, and fill/finish of small-molecule and biologic-based radiopharmaceuticals.
- Analyze production processes; identify and communicate gaps, risks, and inefficiencies; drive process improvements and risk mitigations; lead investigations and root cause analyses.
- Support implementation of cold/hot analytical methods aligned with approved methods, validation requirements, and quality standards.
- Support Regulatory Affairs for IND and new NDA submissions; support inspection readiness, participate in regulatory inspections, and provide audit support.
- Manage technical collaborations with multiple CDMOs to meet project 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.
- Provide first-line technical support for ongoing batch manufacturing (technical questions/escalations).
- Work with Quality Assurance to support manufacturing partners.
Education & Experience / Requirements:
- Bachelor’s/Master’s in science or engineering with >7 years radiopharmaceutical industry experience (including GMP); or PhD with >5 years (including GMP). PET manufacturing, automated synthesis modules, and analytical experience desirable.
- Hands-on experience with isotopes (e.g., F-18, Lu-177, I-131) a plus.
- Leadership/managerial skills; cross-functional experience; managing external CDMOs for compliance and timelines.
- Radiopharmaceutical manufacturing experience, radiation safety principles (ALARA) and applicable regulations.
- Proficiency with MS Office; experience authoring technical/quality documents.
Key Capabilities:
- Autonomy, strong communication, innovation, results-orientation, ethical behavior, adaptability, collaboration, resilience, continuous learning.
Travel expectation: ~10–25%.
- Technical lead of tech transfer and manufacturing activities for drug substance/drug product formulation, radiolabeling, and fill/finish of small-molecule and biologic-based radiopharmaceuticals.
- Analyze production processes; identify and communicate gaps, risks, and inefficiencies; drive process improvements and risk mitigations; lead investigations and root cause analyses.
- Support implementation of cold/hot analytical methods aligned with approved methods, validation requirements, and quality standards.
- Support Regulatory Affairs for IND and new NDA submissions; support inspection readiness, participate in regulatory inspections, and provide audit support.
- Manage technical collaborations with multiple CDMOs to meet project 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.
- Provide first-line technical support for ongoing batch manufacturing (technical questions/escalations).
- Work with Quality Assurance to support manufacturing partners.
Education & Experience / Requirements:
- Bachelor’s/Master’s in science or engineering with >7 years radiopharmaceutical industry experience (including GMP); or PhD with >5 years (including GMP). PET manufacturing, automated synthesis modules, and analytical experience desirable.
- Hands-on experience with isotopes (e.g., F-18, Lu-177, I-131) a plus.
- Leadership/managerial skills; cross-functional experience; managing external CDMOs for compliance and timelines.
- Radiopharmaceutical manufacturing experience, radiation safety principles (ALARA) and applicable regulations.
- Proficiency with MS Office; experience authoring technical/quality documents.
Key Capabilities:
- Autonomy, strong communication, innovation, results-orientation, ethical behavior, adaptability, collaboration, resilience, continuous learning.
Travel expectation: ~10–25%.