Biologics Process Lead Scientist — Hybrid

OpenKrill; United States; Hybrid; USD 150,000 - 230,000; Full time

Job summary

Telix Pharmaceuticals is seeking a Principal Scientist, Biologics to lead a therapeutic program across analytical, purification, formulation, or bioconjugation. You will drive development activities and manage projects with internal sites and external CMC partners.

You will mentor scientists, contribute to IND/NDA/BLA submissions, and ensure GMP/CQMS compliance within a collaborative, global team environment.

Qualifications

• Science or engineering degree with extensive relevant experience.
• Experience managing GMP quality systems and CMC compliance.
• Ability to lead cross-functional project teams and initiatives.
• Experience supporting regulatory filings (IND/NDA/BLA).
• Willingness to travel 10–25% for meetings and site visits.

Responsibilities

• Leads development projects across analytical, purification, formulation, or bioconjugation to deliver clinical drug substance intermediates.
• Reviews manufacturing documents and data packages to support clinical manufacturing.
• Ensures compliance within a Quality system and drives CAPA and change control.
• Authors/reviews CMC content to support regulatory submissions (IND/NDA/BLA).
• Coordinates internal/external collaborations, manages deliverables and risk assessments.

Skills

GMP experience

CMC compliance

Project management

Cross-functional collaboration

Biologics process development

Education

BS in science/engineering

MS in science/engineering

PhD in science/engineering

Job description

Telix Pharmaceuticals is seeking a Principal Scientist, Biologics to lead a therapeutic program across analytical, purification, formulation, or bioconjugation. You will drive development activities and manage projects with internal sites and external CMC partners.

You will mentor scientists, contribute to IND/NDA/BLA submissions, and ensure GMP/CQMS compliance within a collaborative, global team environment.