Telix Pharmaceuticals Limited

Developing theranostics (nuclear medicine) for prostate, kidney, glioblastoma, haematologic cancers and rare diseases.

Director, Biologics

DirectorDirectorFull TimeRemoteTeam 501-1,000Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

109 days ago

Salary

Not specified

Bachelor Degree17 yrs expExperience acceptedEnglish

Job Description

• Oversee process development and clinical production of radiolabeled monoclonal antibodies and conjugates. • Guide late-phase development and commercialization strategy. • Manage a team of bioprocess and bioconjugation scientists and engineers. • Ensure readiness for scale-up and manufacturing. • Ensure Biologics deliverables comply with GMP requirements across multiple regions. • Engage in cross-functional program matrix teams by providing options analysis and program timeline input. • Ensure appropriate source documentation to support regulatory filings.

Job Requirements

  • Bachelor’s degree plus 17 years of experience, or Masters degree or PhD plus 10 years of experience, in bioprocess development, validation, and commercialization.
  • 5+ years in leadership, ideally managing global teams and external partners (e.g., CDMOs)
  • 10 years of experience in GMP, quality management system, and CMC compliance and regulation.
  • Strong written and verbal communication skills are required.
  • Experience working with radiolabeled antibodies is preferred.
  • Experience of contributing to regulatory filings is preferred.

Benefits

  • Competitive salaries
  • Annual performance-based bonuses
  • Equity-based incentive program
  • Generous vacation
  • Paid wellness days
  • Support for learning and development

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