CMC Program Lead: Radiopharma Global Launch (Hybrid/Remote)

Telix Pharmaceuticals Limited; United States; Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Equity incentives

Annual bonuses

Generous vacation

Job summary

Telix Pharmaceuticals in the United States is seeking a CMC Program Lead for commercial/pre-commercial radiochemistry to ensure readiness of radiopharmaceutical assets for launch and lifecycle management. You will lead cross-functional teams across Manufacturing, Quality, Regulatory, and Supply Chain to deliver integrated CMC plans.

The role requires 8+ years in radiopharmaceutical/biopharma CMC with program management experience, strong communication, and familiarity with FDA/global regulatory

Qualifications

• Bachelor-level degree in science/engineering or related field required.
• 8+ years in radiopharmaceutical/biopharma CMC with 2+ years in program management.
• Experience with cross-functional teams, CDMOs, and regulatory requirements.

Responsibilities

• Lead CMC strategies and deliverables for radiopharmaceutical candidates through development to filing and lifecycle management.
• Represent CMC in global matrix teams; manage dashboards, timelines, budgets.
• Coordinate with Procurement, Quality, and regulatory to align plans.
• Communicate risks, issues, and KPIs to senior management; drive decision making.
• Partner with CDMOs and internal Telix teams to ensure smooth handoffs to commercial.

Skills

Cross-functional collaboration

Program management

Regulatory knowledge

Communication skills

Project planning

Education

BS in Science/Engineering

Tools

MS Office

SAP

MS Project

Smartsheet

Job description

Telix Pharmaceuticals in the United States is seeking a CMC Program Lead for commercial/pre-commercial radiochemistry to ensure readiness of radiopharmaceutical assets for launch and lifecycle management. You will lead cross-functional teams across Manufacturing, Quality, Regulatory, and Supply Chain to deliver integrated CMC plans.

The role requires 8+ years in radiopharmaceutical/biopharma CMC with program management experience, strong communication, and familiarity with FDA/global regulatory