Telix Pharmaceuticals Limited · 1 month ago
Principal Scientist, Biologics
United States
Full-time
Remote
Lead/Staff
8+ years expTelix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with a mission to deliver on the promise of precision medicine. The Principal Scientist, Biologics will provide technical and analytical expertise for late phase biologics process development and commercial manufacturing activities, supporting the international roll-out of approved products and advancing the portfolio in oncology and rare diseases.
Biotechnology
Responsibilities
Leads development projects 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 produces clinical and/or commercial drug substance
Authors, reviews, and approves external manufacturing operation documents such as 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, quality investigations, corrective actions, and change control within a Quality system
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, and manages timely deliverables
Experience in the commercialization of several programs from last cycle process development including optimization, process characterization, robustness, reproducibility, through process validation (process definition/ lock, PPQ, & CPV)
Mentors Senior Scientists and other level Scientists on both technical topics as well as Telix values
Qualification
Required
Science or engineering degree with minimum relevant experience as applicable: BS with 11+ years of experience, MS with 9+ years of experience, PhD with 8+ years of experience
6+ 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
Travel expectation: 10 – 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments
Leads development projects 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
Authors, reviews, and approves external manufacturing operation documents such as 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, quality investigations, corrective actions, and change control within a Quality system
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, and manages timely deliverables
Experience in the commercialization of several programs from last cycle process development including optimization, process characterization, robustness, reproducibility, through process validation (process definition/ lock, PPQ, & CPV)
Mentors Senior Scientists and other level Scientists on both technical topics as well as Telix values
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
Annual performance-based bonuses
An equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development
Company
Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$493.27MKey Investors
Australian Government
2024-07-23Post Ipo Debt· $429.77M
2022-04-04Grant· $23M
2020-03-16Grant· $0.5M
Leadership Team
Christian Behrenbruch
Group CEO and Managing Director
Kevin Richardson
CEO Americas
Recent News
Benzinga.com
2026-01-22
legacy.thefly.com
2026-01-21
BioWorld Financial Watch
2026-01-21
Company data provided by crunchbase