Senior Radiopharmaceutical Process Engineer

Telix Pharmaceuticals (AMER); Oregon; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid and remote work options

Bonuses and equity incentives

Generous vacation and wellness days

Learning and development support

Job summary

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

Qualifications

• 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)

Responsibilities

• 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

Skills

Leadership

Cross-functional collaboration

GMP

Radiopharmaceuticals

Regulatory compliance

Education

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

PhD in science or engineering

Tools

MS Office

Excel

Word

Project

Job description

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