CMC Program Lead TLX597 & TLX66

The posting, as Telix Pharmaceuticals (AMER) wrote it

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

The CMC Program Lead for TLX597 &TLX66 is responsible for leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix for early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets developed under a co-development collaboration. The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug Product, Analytical Development, and Supply Chain from preclinical development through phase 3. As the cross-functional integrator, the CMC Lead is the accountable owner for all CMC deliverables, establishing relationships with functional SMEs, internal manufacturing sites, and external partners to drive alignment, decision documentation, risk management, and Stage-Gate readiness. This position is part of the CMC Programs team within the Radiopharmaceutical Development group in Global Operations.

Key Accountabilities

• Develop, own, and execute CMC strategies for antibody-based radiopharmaceutical drug candidates across the TLX597 &TLX66portfolio, from preclinical development through clinical supply. Apply QbD principles (target product profile, critical quality attributes, critical process parameters, control strategy) to drive science-based CMC development aligned to Stage-Gate expectations and readiness criteria
• Serve as the single point of accountability and key point of contact for all CMC matters within the TLX597 &TLX66program matrix. Lead the CMC Sub-Team and represent the CMC function within the broader program governance structure, ensuring all CMC questions, decisions, and deliverables are coordinated through a single accountable owner
• Lead the CMC Sub-Team for assigned programs, coordinating functional SMEs across Drug Substance (antibody/bioconjugate), Drug Product (radiochemistry/fill-finish), Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC across multiple Telix sites. In partnership with SMEs, own cross-functional integration and ensure CMC development activities are executed following QbD principles and sound scientific rationale
• Own and maintain the integrated CMC plan, risk register, decision log, and project dashboards for assigned programs, ensuring CMC time

[…]
s to challenges

• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

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.

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