Job Description
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. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
This role provides technical and analytical expertise for late phase and commercial biologics process development and clinical manufacturing activities for a specific technology area such as cell banking, cell culture, purification, formulation, or bioconjugation ensuring manufacturing processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for managing tasks, activities, and projects at external CDMO partners, as well as contributing to internal cross-functional collaborations to develop and execute process development studies, clinical manufacturing, and validation activities.
The Senior Scientist, Biologics should be comfortable communicating with cross-functional teams in formal settings and third-party meetings, be very knowledgeable in their focus technology area, and manage their own workload to complete assignments with some feedback from colleagues and/or their manager.
Key Accountabilities:
- Designing and documenting development projects for a specific technology area (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 a specific technology area (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) to produce clinical and/or commercial drug substance.
- Ensures appropriate compliance of a specific technology area (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 a specific technology area (e.g. cell culture, purification, formulation, or bioconjugation) to support IND, NDA, BLA and similar regulatory agency applications.
- Independently collaborate with external partners such as CDMOs to assess capabilities, coordinate activities, troubleshoot and analyze operational performance, conduct risk assessments, and ensure timely deliverables.
Education and Experience:
- Science or engineering degree with minimum relevant experience as applicable: BS with 8 years of experience, MS with 6 years of experience, 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.
- 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 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
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals 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.
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