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Telix Pharmaceuticals
USA- Remote
Source: Telix Pharmaceuticals careers · View original posting
From Telix Pharmaceuticals's posting. “We” and “our” refer to the employer.
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
This role provides technical support and training for radiopharmaceutical preparation as well as participating in validation activities, CDMO (Contract Development/Manufacturing Organization) qualification initiatives, technical transfers, troubleshooting, and continuous improvement endeavors. Role will provide leadership and technical expertise - both internally and externally - to cross-functional teams as well as support field execution with focus on compliance with industry regulations, quality standards, and regulatory
frameworks. This role also provides first line technical support for ongoing batch manufacturing.
Technical lead of tech transfer and manufacturing activities related to drug substance and drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals
Analyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analyses
Support implementation of cold and hot analytical methods under the guidance of internal QC SMEs, ensuring alignment with approved methods, validation requirements, and quality standard.
Provide support to Regulatory Affairs for product IND and new NDA submissions, support inspection readiness, participate in regulatory agency inspections, and provide audit support, as required
Bachelor’s or Master’s degree in science or engineering with > 7 years of experience in the radiopharmaceutical industry, including GMP; or PhD in science or engineering with >5 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP. PET manufacturing, handling of automated synthesis modules, and analytical experience is desirable
Hands‑on experience with multiple isotopes like F-18, Lu-177 and I-131 etc. are a plus for this position
Demonstrated leadership and managerial skills
Experience working cross-functionally with a team of internal scientists and engineers, managing external CDMOs to ensure compliance with project timelines/cGMPs, and on-going manufacturing operations
Autonomy: Comfortable working independently with senior-level support
Strong communication skills: Able to communicate effectively with internal and external colleagues and stakeholders, using clear and concise language.
. 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.
VIEW OUR PRIVACY POLICY HERE
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.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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