Senior Bioprocess Scientist

1 month ago

Melbourne, Australia Telix Full time

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.

As the Senior Bioprocess Scientist, you will provide technical and analytical support for early-phase biologics manufacturing and bio-conjugation activities. Your primary focus will be to advance pre- and early clinical pipelines by ensuring manufacturing processes are efficient and compliant with regulatory requirements and meet quality and safety standards.

The Senior Bioprocess Scientist is expected to demonstrate excellent project management and communication skills, strong attention to detail, and in-depth understanding of biologics manufacturing technologies, quality and regulations.

What you’ll do

  • Develop and execute CMC plans with allocated timeline and budget to perform manufacturing activities such as assay development.
  • Liaise CDMOs and CROs and Telix cross-functional teams for manufacturing activities, such as vendor selection and qualification, proposal/contract/agreement execution.
  • Coordinate, monitor and provide technical support to CDMOs and CROs to deliver target materials on time and on budget.
  • Monitor and analyze manufacturing performance data and reports to identify areas for improvement.
  • Work with quality, regulatory and CMC stakeholders to ensure compliance with all relevant regulatory requirements.
  • Support the asset and project management teams with timeline and budget planning, risk assessment and mitigation, and internal reporting and external communications.
  • Support internal and external stakeholders in engagements, communications, and regulatory submissions with regulatory agencies.

About you

  • 7+ years of biopharmaceutical development and manufacturing experience across a breadth of functions including, but not limited to, research and development, manufacturing operations, quality and compliance.
  • Bachelor’s degree or higher required.
  • Knowledge of GMP, quality management system, and CMC compliance and regulations.
  • Proven understanding and application of project management principle and tools
  • The ability to work with cross-functional teams.

Why work at Telix?

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. 

VIEW OUR PRIVACY POLICY HERE

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