Senior Principal Scientist, Biologics – Translational Medicine
Telix Pharmaceuticals is a dynamic, fast‑growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.
This role provides technical and analytical expertise for translational to early‑phase biologics process development and manufacturing activities, ensuring developability and manufacturability assessments and drug‑substance intermediates are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance.
Key Accountabilities
Oversee development projects for multiple technology areas, ensuring the appropriate developability and manufacturability assessments to enable future process knowledge, technology transfer, analytical method transfer, and design‑space definition, to produce preclinical and/or clinical drug‑substance intermediates.
Oversee external manufacturing projects to deliver SOPs, batch records, protocols, and reports for multiple technology areas to produce preclinical and/or clinical drug‑substance intermediates, including monoclonal antibody or other molecule type bulk, bioconjugate bulk, and vial components.
Author and/or review source documents and CMC content related to several technology areas to support early IB, IMPD, and similar regulatory applications, ensuring appropriate document curation, storage, and compliance within a Quality system.
Lead collaborations with external partners to develop selection criteria, assess capabilities, coordinate activities, plan process technology transfer/analytical method transfer, troubleshoot and analyze operational performance, conduct risk assessments, and manage timely deliverables.
Mentor other level Scientists on both technical topics and Telix values.
Education & Experience
Science or engineering degree with minimum relevant experience: BS with 14 years, MS with 12 years, PhD with 11 years.
Minimum 10 years of experience in translational to early‑phase 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.
Key Capabilities
Inclusive mindset: Demonstrate an understanding and appreciation for diversity and actively work to create an inclusive environment.
Creativity and innovation: Possess a willingness to think outside the box and come up with unique 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.
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.
Telix is an equal‑opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Frasnes-lez‑Gosselies, Belgium
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