Senior Scientist, Biologics

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Provide technical and analytical expertise for late-phase biologics process development and manufacturing activities • Manage projects in a specific technology area at external CDMO partners • Contribute to internal cross-functional collaborations for clinical and/or commercial manufacturing • Design and document development projects, including process knowledge, technology transfer, analytical method transfer, design space, control strategy definition, optimization, and validation • Author, review, and approve external manufacturing documents, including SOPs, batch records, protocols, and reports • Ensure compliance through document creation, review and approval, quality investigations, corrective actions, and change control within a Quality system • Author and/or review source documents and CMC content supporting IND, NDA, BLA, and similar regulatory applications • Collaborate with CDMOs to assess capabilities, coordinate activities, troubleshoot, analyze operational performance, conduct risk assessments, and ensure timely deliverables

🎯 Requirements

• Science or engineering degree with minimum relevant experience: BS with 8 years of experience, MS with 6 years of experience, or PhD with 5 years of experience • Minimum 5 years of experience in GMP, quality management system, and CMC compliance and regulation • Demonstrated understanding and application of project management principles and tools • Ability to work in cross-functional, virtual teams • Technical and analytical expertise in a specific biologics technology area, such as cell banking, cell culture, purification, formulation, or bioconjugation • Ability to communicate with cross-functional teams in formal settings and third-party meetings • Ability to identify risks and needed deliverables and manage workload with limited feedback • Travel expectation of 10–25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments

🏖️ Benefits

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Hybrid and remote work arrangements are available across Telix • Supportive, engaged global interdisciplinary team

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