Principal Scientist, Biologics

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧬 Research Scientist

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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 early-phase biologics process development and manufacturing activities • Manage projects across analytical, purification, formulation, and bioconjugation technology areas • Act as the Biologics lead for a specific therapeutic program • Lead development projects involving process knowledge, technology transfer, analytical method transfer, design space, control strategy definition, optimization, and qualification • Review and approve SOPs, batch records, protocols, analytical procedures, and development reports • Ensure compliance through document creation, review and approval, quality investigations, corrective actions, and change control within a Quality system • Author and review source documents and CMC content for IND, NDA, BLA, and similar regulatory applications • Lead collaborations with internal sites and external CMC partners, including capability assessment, activity coordination, planning, troubleshooting, risk assessments, and deliverable management • Mentor Senior Scientists and other Scientists on technical topics and Telix values • Contribute to cross-functional collaborations to develop and execute clinical manufacturing

🎯 Requirements

• Science or engineering degree with one of the following experience combinations: BS with 11 years of experience, MS with 9 years of experience, or PhD with 8 years of experience • Minimum 5 years of experience in GMP, quality management system, and CMC compliance • Demonstrated understanding and application of project management principles • Ability to work in cross-functional, virtual teams • Technical knowledge in multiple biologics technology areas, including analytical, purification, formulation, or bioconjugation • Ability to communicate with cross-functional teams in formal settings and third-party meetings • Ability to manage workload autonomously, with feedback for complicated topics • Willingness to travel 10–25% for key in-person meetings, partner site visits, and SME/technical person-in-plant • Experience supporting regulatory applications such as IND, NDA, and BLA, including comparability and risk-based approaches

🏖️ Benefits

• Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Remote work arrangement