Sustainability Engineer
Telix Pharmaceuticals Limited
August 30, 2026
Remote friendly (United States)
United States
Corporate Functions
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 and report results; 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 to ensure alignment with approved methods, validation requirements, and quality standards.
- Support Regulatory Affairs for IND and new NDA submissions; support inspection readiness, regulatory agency inspections, and audits as required.
- Manage technical collaborations with multiple CDMOs to meet project milestones.
- Author/review SOPs, batch records, protocols, and reports for clinical and/or commercial products.
- Ensure compliance via document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
- Follow procedures to support intellectual property protection.
- Provide first-line technical support for ongoing batch manufacturing (technical questions/concerns/escalations).
- Collaborate with Quality Assurance to support manufacturing partners.
Education and Experience:
- Bachelor’s/Master’s in science or engineering with >7 years radiopharmaceutical industry experience (incl. GMP), or PhD with >5 years (incl. GMP); PET manufacturing/automated synthesis modules/analytical experience desirable.
- Hands-on experience with multiple isotopes (e.g., F-18, Lu-177, I-131) is a plus.
- Demonstrated leadership/managerial skills.
- Cross-functional experience; manage external CDMOs to ensure timelines/cGMPs and manufacturing operations.
- Knowledge of radiation safety principles, ALARA, and applicable regulatory requirements.
- MS Office experience (Excel, Word, Project).
- Experience authoring technical documents (protocols, reports, SOPs, quality investigations).
- Experience in radiopharmaceutical and process development.
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 and report results; 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 to ensure alignment with approved methods, validation requirements, and quality standards.
- Support Regulatory Affairs for IND and new NDA submissions; support inspection readiness, regulatory agency inspections, and audits as required.
- Manage technical collaborations with multiple CDMOs to meet project milestones.
- Author/review SOPs, batch records, protocols, and reports for clinical and/or commercial products.
- Ensure compliance via document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
- Follow procedures to support intellectual property protection.
- Provide first-line technical support for ongoing batch manufacturing (technical questions/concerns/escalations).
- Collaborate with Quality Assurance to support manufacturing partners.
Education and Experience:
- Bachelor’s/Master’s in science or engineering with >7 years radiopharmaceutical industry experience (incl. GMP), or PhD with >5 years (incl. GMP); PET manufacturing/automated synthesis modules/analytical experience desirable.
- Hands-on experience with multiple isotopes (e.g., F-18, Lu-177, I-131) is a plus.
- Demonstrated leadership/managerial skills.
- Cross-functional experience; manage external CDMOs to ensure timelines/cGMPs and manufacturing operations.
- Knowledge of radiation safety principles, ALARA, and applicable regulatory requirements.
- MS Office experience (Excel, Word, Project).
- Experience authoring technical documents (protocols, reports, SOPs, quality investigations).
- Experience in radiopharmaceutical and process development.
Travel expectation: ~10–25%.