Director, Biologics
Telix Pharmaceuticals Limited
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
bioprocess developmentbioconjugationGMP compliancequality management systemCMC complianceregulatory filingsradiolabeled antibodiescommercialization strategyprocess developmentscale-up manufacturing
Soft skills
leadershipteam managementcommunication skillscross-functional collaborationoptions analysisprogram timeline management
Certifications
Bachelor’s degreeMaster’s degreePhD