Global Manufacturing Engineer

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
The Manufacturing Engineer – Global will contribute to the achievement of the company’s clinical and commercial assets. This role will be responsible for assisting in design, implementation and review of procedures, equipment, facilities, in-process controls, and release testing involved in pharmaceutical manufacturing processes. Duties include researching current and future manufacturing/testing systems for efficiency and optimization of production along with being as a subject matter expert (SME) for Chemistry, Manufacturing, and Controls (CMC) activities for Telix’s programs from developmental through commercial manufacturing and supply.
Key Accountabilities

• Ownership of CMC activities related to bulk formulation, fill/finish, lyophilization, and packaging manufacturing processes of small molecules and biologics.
• Evaluate manufacturing processes to ensure efficiency, safety, and compliance with relevant regulations and standards.
• Analyze production processes, schedules, test methods and other data. Identify risks, gaps, and inefficiencies. Drive implementation of process improvements and risk mitigations.
• Work collaboratively with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestones.
• Support authorship and submission of CMC sections in IND, IMPD, NDA, and/or BLA filings.
• Design and develop robust processes throughout the product lifecycle from early-stage clinical through commercialization.
• Build strategies to support eventual process performance qualification (PPQ) of manufacturing processes.
• Ensure the company’s external manufacturing processes follow all government laws and regulations by working closely with the Regulatory and Quality teams.
• Effectively support internal and external resources to achieve project milestones.
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.
• Work with Manufacturing team to ensure on-time delivery of high-quality products for clinical and commercial supply.
• Preparation and delivery of accurate reports to support investigations, process improvements, risk assessment and change implementation.
• Provide technical support to CDMOs to support and push through improvement and efficiency initiatives.
• Develop and maintain manufacturing attribute tracking and trending to identify out-of-control operations and establish critical quality attributes/in-process controls.
  

Education And Experience

• 5+ years of operational pharmaceutical experience across a breadth of functions including but not limited to, manufacturing operations, bioprocessing technology, validation
• Bachelor’s degree or higher in engineering or science-related field applicable to pharmaceutical operations
• Robust knowledge of GMP and regulations. Also possesses a strong technical understanding of manufacturing, product/process development, and analytical method development.
• Demonstrated understanding of core pharmaceutical business functions
• Proven track record of analytical problem solving and successful process design/implementation
• Must have strong experience in MS Office suite applications (e.g., Excel, Word, Project)
• Experience working with cross-functional teams, external partners and CDMOs
  

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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