Senior Principal Scientist, Biologics

Summary

Join Telix Pharmaceuticals as a Senior Principal Scientist, Biologics and contribute to the international rollout of our prostate cancer imaging agent and the advancement of our late clinical-stage products. This role demands technical and analytical expertise in biologics process development and manufacturing, ensuring processes meet program objectives, safety standards, and regulatory expectations. You will manage projects at external CDMO partners and collaborate internally to develop and execute clinical and commercial manufacturing. As a subject matter expert, you will lead one or more therapeutic programs, communicate with cross-functional teams, and mentor other scientists. The position requires extensive experience in GMP, quality management, and CMC compliance, along with a strong understanding of project management. Telix offers competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days, and support for learning and development.

Requirements

• Science or engineering degree with minimum relevant experience as applicable: BS with 14+ years of experience, MS with 12+ years of experience or PhD with 11+ years of experience
• 14+ years of experience in GMP, quality management system, and CMC compliance and regulation
• Life-cycle experience in Phase III products as well as Commercialization of processes
• Experience in leading BLA-enabling studies and data packages
• Demonstrated understanding and application of project management principles and tools
• Ability to work in cross-functional, virtual teams

Responsibilities

• Oversee process development and commercialization for multiple technology areas (e.g., cell banking, cell culture, purification, formulation, or bioconjugation) ensuring the appropriate process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or validation to produce clinical and/or commercial drug substance
• Oversee external manufacturing operation projects to deliver SOPs, batch records, protocols, and reports for multiple technology areas (e.g., cell banking, cell culture, purification, formulation, or bioconjugation) to produce clinical and/or commercial drug substance
• Ensures appropriate compliance of multiple technology areas (e.g., cell banking, cell culture, purification, formulation, or bioconjugation) through document creation/review/approval, corrective actions, and change control within a Quality system including complex quality investigations with advanced root cause analyses
• Authors and/or reviews source documents and CMC content related to several technology areas (e.g., cell culture, purification, formulation, or bioconjugation) to support IND, NDA, BLA and similar regulatory agency applications, especially in areas requiring more sophisticated acumen such as comparability and risk-based approach justifications
• Leads collaborations with external partners such as CDMOs to develop selection criteria, assess capabilities, coordinate activities, plan process technology transfer/analytical method transfer, troubleshoot and analyze operational performance, conduct risk assessments, guide complicated exceptions for TT and/or validation protocols, and manages timely deliverables
• Mentors other level Scientists on both technical topics as well as Telix values

Preferred Qualifications

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

Benefits

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