Telix Pharmaceuticals
radiopharmaceutical
SustainabilityEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Sustainability Engineer at Telix Pharmaceuticals. Skills: technical lead of tech transfer and manufacturing activities, drug substance and drug product formulation, radiolabeling, fill/finish of small molecule and biologic based radiopharmaceuticals, Analyze production processes, Drive implementation of process improvements, Lead manufacturing investigations and root cause analyses, Support implementation of cold and hot analytical methods, Support to Regulatory Affairs for product IND and new N”
What You'll Achieve.
deliver on the promise of precision medicine through targeted radiation; create products that seek to improve the quality of life for people living with cancer and rare diseases; supporting the international roll-out of our approved prostate cancer imaging agent; helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases; achieve key project milestones; produce clinical and/or commercial products; deliver measurable results
Industry & Context.
troubleshooting; manufacturing investigations and root cause analyses; Identify and communicate gaps, risks, and inefficiencies.; Drive implementation of process improvements and risk mitigations.
~10-25% (including international, overnight, and weekend) may be required for key in-person meetings, partner site visits, and SME/technical assignments
What They're Looking For.
Must Have
Bachelor’s or Master’s degree in science or engineering with > 7 years of experience in the radiopharmaceutical industry, including GMP, PhD in science or engineering with >5 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP, Demonstrated leadership and managerial skills, Experience working cross-functionally with a team of internal scientists and engineers, managing external CDMOs to ensure compliance with project timelines/cGMPs, and on-going manufacturing operations, Experience working in radiopharmaceutical manufacturing environments, including knowledge of radiation safety principles, ALARA, and applicable regulatory requirement, Experience in MS Office suite applications (e. g. , Excel, Word, Project), Experience in authoring challenging technical documents, including but not limited to, protocols, reports, SOPs, and quality investigations, Experience in radiopharmaceutical and process development
Nice to Have
PET manufacturing, handling of automated synthesis modules, and analytical experience is desirable, Hands‑on experience with multiple isotopes like F-18, Lu-177 and I-131 etc. are a plus for this position
What You'll Do.
Technical lead of tech transfer and manufacturing activities related to drug substance and drug product formulation
and fill/finish of small molecule and biologic based radiopharmaceuticals
Analyze production processes and report results.
Identify and communicate gaps
Drive implementation of process improvements and risk mitigations.
Lead manufacturing investigations and root cause analyses
Support implementation of cold and hot analytical methods under the guidance of internal QC SMEs
ensuring alignment with approved methods
validation requirements
and quality standard.
Provide support to Regulatory Affairs for product IND and new NDA submissions
support inspection readiness
participate in regulatory agency inspections
and provide audit support
Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones
Author and review documents such as SOPs
and reports to produce clinical and/or commercial products
Ensure appropriate compliance through document creation/review/approval
quality investigations
and change control within a Quality system
Follows procedures to support intellectual property protection
Provide first line technical support for ongoing batch manufacturing as the first point of contact for technical questions
Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners
How You'll Work.
Team & Collaboration
leadership and technical expertise - both internally and externally - to cross-functional teams; Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners; Experience working cross-functionally with a team of internal scientists and engineers, managing external CDMOs; Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Communication Scope
Able to communicate effectively with internal and external colleagues and stakeholders, using clear and concise language.
Process & Methodology
Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones
Full Job Description
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 This role provides technical support and training for radiopharmaceutical preparation as well as participating in validation activities, CDMO (Contract Development/Manufacturing Organization) qualification initiatives, technical transfers, troubleshooting, and continuous improvement endeavors. Role will provide leadership and technical expertise - both internally and externally - to cross-functional teams as well as support field execution with focus on compliance with industry regulations, quality standards, and regulatory frameworks. This role also provides first line technical support for ongoing batch manufacturing. Key Accountabilities: Technical lead of tech transfer and manufacturing activities related to drug substance and drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals 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 analyses Support implementation of cold and hot analytical methods under the guidance of internal QC SMEs, ensuring alignment with approved methods, validation requirements, and quality standard. Provide support to Regulatory Affairs for product IND and new NDA submissions, suppor
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