Sustainability Engineer

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company dedicated to precision medicine. The Sustainability Engineer role involves providing technical support and leadership in radiopharmaceutical preparation, compliance with industry regulations, and continuous improvement initiatives.

Responsibilities:

• 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, support inspection readiness, participate in regulatory agency inspections, and provide audit support, as required
• Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones
• Author and review documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products
• Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, 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, concerns, and/or escalations
• Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners

Requirements:

• Bachelor's or Master's degree in science or engineering with > 7 years of experience in the radiopharmaceutical industry, including GMP; or 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
• 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, support inspection readiness, participate in regulatory agency inspections, and provide audit support, as required
• Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones
• Author and review documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products
• Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, 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, concerns, and/or escalations
• Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners
• 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
• 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