Senior Scientist, Biologics

Telix Pharmaceuticals (AMER)

14h

About The Position

Telix Pharmaceuticals is a fast-growing radiopharmaceutical company with offices in Australia, Belgium, Japan, Switzerland, and the United States. Its mission is to advance precision medicine through targeted radiation and develop products intended to improve quality of life for people living with cancer and rare diseases. The Senior Scientist, Biologics provides technical and analytical expertise for late-phase biologics process development and manufacturing in a specific technology area, such as cell banking, cell culture, purification, formulation, or bioconjugation. The role ensures processes are developed to meet program objectives, safety standards, regulatory expectations, and quality requirements. It manages projects in the relevant technology area with an external CDMO partner and contributes to internal cross-functional work to develop and execute clinical and/or commercial manufacturing. The successful candidate communicates comfortably with cross-functional teams and third parties, brings strong expertise in their focus technology area, identifies risks and required deliverables, and manages their workload with some feedback from colleagues or their manager. The position involves an expected 10–25% travel for key in-person meetings, partner site visits, and subject-matter expert or technical person-in-plant assignments.

Requirements

Science or engineering degree.
Relevant experience by degree: BS with 8 years, MS with 6 years, or PhD with 5 years.
Minimum 5 years of experience in GMP, quality management systems, and CMC compliance and regulation.
Demonstrated understanding and application of project management principles and tools.
Ability to work in cross-functional, virtual teams.
Strong knowledge of a relevant technology area, such as cell banking, cell culture, purification, formulation, or bioconjugation.
Strong communication and collaboration skills, with the ability to communicate with cross-functional teams and third parties.
Ability to take initiative, identify risks and required deliverables, and manage workload with some feedback from colleagues and/or a manager.
Willingness to travel 10–25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments.

Responsibilities

Design and document development projects in a specific technology area, including process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or validation for clinical and/or commercial drug substance production.
Author, review, and approve external manufacturing operation documents, including SOPs, batch records, protocols, and reports.
Ensure compliance in the relevant technology area through document creation, review, and approval, quality investigations, corrective actions, and change control within a Quality system.
Author and/or review source documents and CMC content related to the relevant technology area to support IND, NDA, BLA, and similar regulatory applications.
Collaborate independently with external partners such as CDMOs to assess capabilities, coordinate activities, troubleshoot and analyze operational performance, conduct risk assessments, and ensure timely deliverables.
Contribute to internal cross-functional collaborations to develop and execute clinical and/or commercial manufacturing.