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CMC Program Lead

Telix PharmaceuticalsCanada - RemoteNew
Remote Full-time

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Experience Level

Manager

Qualifications

Key Responsibilities:Develop, own, and implement CMC strategies for antibody-based radiopharmaceutical drug candidates throughout the portfolio, from preclinical development to clinical supply. Leverage QbD principles (target product profile, critical quality attributes, critical process parameters, control strategy) to drive science-based CMC development that meets Stage-Gate expectations and readiness criteria. Act as the sole point of accountability and primary contact for all CMC matters within the program matrix. Lead the CMC Sub-Team and represent the CMC function within the broader program governance structure, ensuring that all CMC inquiries, decisions, and deliverables are managed through a single accountable entity. Lead the CMC Sub-Team for assigned programs, coordinating functional SMEs across Drug Substance (antibody/bioconjugate), Drug Product (radiochemistry/fill-finish), Analytical Development, Quality Control (QC), Quality Assurance (QA), Supply Chain, Validation, and Regulatory CMC.

About the job

Telix Pharmaceuticals is a dynamic and rapidly expanding radiopharmaceutical company headquartered in Australia, with additional offices in Belgium, Japan, Switzerland, and the United States. Our mission is to fulfill the promise of precision medicine through targeted radiation therapies. Our core purpose is to develop innovative products that enhance the quality of life for patients battling cancer and rare diseases. In this role, you will be instrumental in supporting the global rollout of our prostate cancer imaging agent while also contributing to the advancement of our portfolio of late clinical-stage products that address significant unmet needs in oncology and rare diseases.

Join Us at Telix

The CMC Program Lead will spearhead the CMC Sub-Team, acting as the primary point of contact for all CMC matters within the program matrix for our early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets. You will be responsible for developing, executing, and maintaining an integrated CMC strategy and plan based on Quality by Design (QbD) principles, ensuring alignment with Stage-Gate requirements. This encompasses Drug Substance, Drug Product, Analytical Development, and Supply Chain from preclinical development through the end of Phase 1 (first-in-human studies). As the cross-functional integrator, you will take ownership of all CMC deliverables, fostering relationships with functional Subject Matter Experts (SMEs), internal manufacturing sites, and external partners to facilitate alignment, documentation of decisions, risk management, and Stage-Gate preparedness.

About Telix Pharmaceuticals

Telix Pharmaceuticals is at the forefront of innovation in the radiopharmaceutical sector, committed to improving patient outcomes through cutting-edge therapies. With a global presence and a focus on precision medicine, Telix strives to address significant healthcare challenges in oncology and rare diseases, making a meaningful impact on patients' lives worldwide.

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