Telix Pharmaceuticals Limited logo
Telix Pharmaceuticals Limited

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

Sustainability Engineer

EngineerEngineerFull TimeRemoteLeadTeam 501-1,000Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

10 days ago

Salary

0

Seniority

Lead

Postgraduate Degree7 yrs expEnglish

Job Description

Sustainability Engineer

Telix Pharmaceuticals Limited

• Technical lead of tech transfer and manufacturing activities related to drug substance and drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals • Analyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analyses • Support implementation of cold and hot analytical methods under the guidance of internal QC SMEs, ensuring alignment with approved methods, validation requirements, and quality standards. • Provide support to Regulatory Affairs for product IND and new NDA submissions, support inspection readiness, participate in regulatory agency inspections, and provide audit support, as required • Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones • Author and review documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products • Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system • Follows procedures to support intellectual property protection • Provide first line technical support for ongoing batch manufacturing as the first point of contact for technical questions, concerns, and/or escalations • Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners

Job Requirements

  • Bachelor’s or Master’s degree in science or engineering with > 7 years of experience in the radiopharmaceutical industry, including GMP; or PhD in science or engineering with >5 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP
  • Hands‑on experience with multiple isotopes like F-18, Lu-177 and I-131 etc.
  • Demonstrated leadership and managerial skills
  • Experience working cross-functionally with a team of internal scientists and engineers, managing external CDMOs to ensure compliance with project timelines/cGMPs, and on-going manufacturing operations
  • Experience working in radiopharmaceutical manufacturing environments, including knowledge of radiation safety principles, ALARA, and applicable regulatory requirement
  • Experience in MS Office suite applications (e.g., Excel, Word, Project)
  • Experience in authoring challenging technical documents, including but not limited to, protocols, reports, SOPs, and quality investigations
  • Experience in radiopharmaceutical and process development

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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