Global CMC Lead for Radiopharmaceuticals - Remote

Telix Pharmaceuticals (AMER); Oregon; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Equity-based incentive program

Annual performance-based bonuses

Generous vacation

Wellness days

Learning and development support

Job summary

Telix Pharmaceuticals is seeking a CMC Program Lead to drive the integrated CMC strategy for TLX597 & TLX66 from preclinical through clinical supply. You will coordinate with Drug Substance, Drug Product, Analytical Development, QC/QA, and Regulatory CMC across Telix sites to ensure Stage-Gate readiness.

You will lead a cross-functional sub-team, manage risk, dashboards, and timelines, and collaborate with internal and external partners to ensure compliant, timely delivery.

Qualifications

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required.
• 10+ years of radiopharmaceutical/pharmaceutical/biopharma CMC experience with 5+ years in CMC program/project management.
• Experience with biologics and/or radiopharmaceuticals is required.
• Experience managing alliance/partnership programs or multi-site CMC execution.
• Strong knowledge of FDA and global regulatory requirements for radiopharmaceuticals and biologics.
• Ability to thrive in a dynamic global environment and travel as needed.

Responsibilities

• Develop and execute CMC strategies for antibody-based radiopharmaceutical candidates across TLX597 & TLX66.
• Lead the CMC Sub-Team and coordinate with SMEs across Drug Substance, Drug Product, Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC.
• Own the integrated CMC plan, risk register, decision log, and project dashboards for Stage-Gate readiness.
• Coordinate with internal sites and external CDMOs/CMOs for Drug Substance and Drug Product supply.
• Partner with R&D, Translational Development, Radiochemistry, Regulatory, and Quality to manage cross-functional dependencies.
• Enable development of CMC transfer packages and handoff documentation for phase transitions.
• Facilitate team meetings and maintain meeting agendas, minutes, and risk analyses.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

BA/BS in Science or related

Job description

Telix Pharmaceuticals is seeking a CMC Program Lead to drive the integrated CMC strategy for TLX597 & TLX66 from preclinical through clinical supply. You will coordinate with Drug Substance, Drug Product, Analytical Development, QC/QA, and Regulatory CMC across Telix sites to ensure Stage-Gate readiness.

You will lead a cross-functional sub-team, manage risk, dashboards, and timelines, and collaborate with internal and external partners to ensure compliant, timely delivery.