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  • 2 weeks ago

jobs 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

To contribute to the achievement of the company’s clinical and commercial assets. Responsible for assisting in design, implementation and review of procedures, protocols, validation reports, specifications, equipment, facilities, in-process controls, and release testing involved in pharmaceutical manufacturing processes of Active Pharmaceutical Ingredients (APIs) in the category of Small Molecules including fill/finish. Duties include researching current and future external manufacturing/testing systems for efficiency and optimization of production. Role will function 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 APIs, bulk formulation, fill/finish, lyophilization, and packaging manufacturing processes of small molecules.
• Ownership of CMC activities with a focus on on-time-delivery of material for clinical use.
• Responsible for on-time-delivery of complete CMC information from CDMO for submissions.
• Participate in the sourcing, selection, and recommendation of contract development/manufacturing organizations CDMO/CMOs.
• Evaluate manufacturing processes, specifications, and validation protocols provided by CDMO/CMOs, to ensure efficiency, safety, and compliance with relevant regulations and standards.
• Analyse 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 CDMOs to provide technical support and achieve key project milestones.
• Lead or participate in investigations for deviations from procedures and Out of Specification events.
• Lead Change Control processes for specification creation and updates.
• Support authorship and submission of CMC sections in IND, IMPD, NDA, and/or BLA filings.
• Lead and support deficiency responses from regulatory agencies occurring from submissions.
• Design phase appropriate and 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 are following 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.

Education And Experience
• 5+ years of operational pharmaceutical experience across a breadth of functions including but not limited to, manufacturing operations, process scale-up, technical transfer, and 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.

VIEW OUR PRIVACY POLICY HERE
United States

salary-criteria

Apply - Global Manufacturing Engineer - API/Small Molecule United States