Senior Scientist, Biologics
Telix Pharmaceuticals (Americas)
Summary
This role provides technical and analytical expertise for late phase biologics process development and manufacturing activities for a specific technology area (e.g. 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 projects in a specific technology area at an external CDMO partner, as well as contributing to internal cross-functional collaborations to develop and execute clinical (and/or commercial) manufacturing.
Job description
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, take initiative to identify risks and needed deliverables, 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 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 to produce clinical and/or commercial drug substance.
- Ensures appropriate compliance of a specific technology area 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 to support IND, NDA, BLA and similar regulatory agency applications.
- Independently collaborates 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
- Commitment to excellence
- Results-oriented
- Creativity and innovation
- Strong communication skills
- Collaboration
- Resilience
- Inclusive mindset
- Adaptability
- Ethical behavior
- Continuous learning
Requirements
- Science or engineering degree with minimum relevant experience: BS with 8 years, MS with 6 years, PhD with 5 years
- 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%
Benefits
- Competitive Salaries
- Annual Performance-Based Bonuses
- Equity-Based Incentive Program
- Generous Vacation
- Paid Wellness Days
- Learning & Development Support
Company overview
Telix Pharmaceuticals (Americas) is the United States operations division of Telix Pharmaceuticals Limited, a global commercial-stage biopharmaceutical company specializing in the development and commercialization of therapeutic and diagnostic radiopharmaceuticals, commonly known as 'theranostics'. Headquartered in Melbourne, Australia with global operations spanning the United States, Europe, and Japan, Telix focuses on precision oncology through targeted radiation therapies. The company's innovative pipeline addresses significant unmet medical needs in urologic oncology (prostate and kidney cancer), neuro-oncology (glioma), musculoskeletal oncology (sarcoma), and bone marrow conditioning. Telix has achieved regulatory approvals from the FDA, TGA, and Health Canada for its prostate cancer imaging agent Illuccix®, and maintains an extensive portfolio of over 18 clinical trials worldwide. As a dynamic, fast-growing radiopharmaceutical company, Telix Pharmaceuticals (Americas) plays a crucial role in the international rollout of approved products and advancement of late clinical-stage therapies, leveraging a global workforce of 1,000-5,000 employees dedicated to improving quality of life for cancer patients through targeted radiation solutions.