Sr. Sustainability Engineer - Radiopharmaceutical Manufacturing

Telix Pharmaceuticals (AMER); Oregon; Híbrido; USD 140.000 - 190.000; Tempo integral

Benefícios oferecidos por esta vaga

Hybrid and remote work options

Bonuses and equity incentives

Generous vacation and wellness days

Learning and development support

Resumo da vaga

Telix Pharmaceuticals is seeking an experienced radiopharmaceutical manufacturing leader to provide technical support and drive tech transfer across drug substance and product formulations. You will supervise radiopharmaceutical production activities, ensure GMP compliance, and coordinate with internal teams and external CDMOs to meet development milestones.

The role emphasizes cross-functional leadership, regulatory readiness, and continuous process improvement within a global, hybrid work

Qualificações

• Bachelor's or Master's degree in science/engineering with >7 years radiopharmaceutical GMP experience
• PhD in science/engineering with >5 years in radiopharmaceutical/biopharmaceutical GMP
• Experience with radiopharmaceutical manufacturing and GMP
• Experience leading cross-functional teams and managing external CDMOs to ensure timelines/cGMPs
• Experience in radiopharmaceutical development and process transfer
• Experience with MS Office suite (Excel, Word, Project)

Responsabilidades

• Technical lead of tech transfer and manufacturing activities for drug substance/product radiopharmaceuticals
• Analyze production processes and report gaps; drive improvements and risk mitigations
• Support analytical method development and validation under QC guidance
• Support Regulatory Affairs for IND/ NDA submissions and inspection readiness
• Manage collaborations with CDMOs to meet project milestones
• Prepare and review SOPs, batch records, protocols, and reports
• Ensure quality systems through investigations, CAPAs, and change control
• Provide first line technical support for batch manufacturing and QA partnership
• Collaborate with Quality Assurance to support manufacturing partners

Conhecimentos

Leadership

Cross-functional collaboration

GMP

Radiopharmaceuticals

Regulatory compliance

Formação

Bachelor's or Master's degree in science or engineering

PhD in science or engineering

Ferramentas

MS Office

Excel

Word

Project

Descrição da vaga

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.

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, 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

Education and Experience:

• 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. 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
• 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

Key Capabilities:

• 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

Travel expectation:

~10-25% (including international, overnight, and weekend) may be required for key in-person meetings, partner site visits, and SME/technical assignments

At Telix, we believe everyone counts , we strive to be extraordinary , and we pursue our goals with determination and integrity . You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer.

We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE