Senior Radiochemist at PETNET Solutions, Inc. in Knoxville, Tennessee

Job Description:

Now's our time to inspire the future of healthcare together.


Siemens Healthineers' PETNET Solutions, a global PET radiopharmaceutical network, leads the way in industry expertise. Providing routine, reliable delivery of high-quality radiopharmaceuticals and services has established us as the trusted partner in PET imaging since 1996.


With more than 47 locations around the globe, Siemens Healthineers PETNET Solutions is the largest supplier of positron emission tomography (PET) radiopharmaceuticals, delivering more than 1,000,000 doses to more than 2,800 imaging centers worldwide, each year. Since 1996 we have delivered more than 6,000,000 doses worldwide.


Because we have the largest network of pharmacies, our pharmacies back each other up. This gives us a dose fulfillment rate of >99%. If you place an order with us, we are successful at dispensing the dose. That is confidence delivered. Check us out: https://www.siemens-healthineers.com/en-us/molecular-imaging/petnet


Job Summary


PETNET is seeking applicants for a Senior Radiochemist position to support the development of PETNET's biomarker portfolio. The successful candidate will manage and execute on projects related to production and analytic chemistry to ensure that manufacturing and QC procedures meet corporate requirements to support GMP operation. This is an ideal role for a candidate with experience manufacturing radiopharmaceuticals and managing complex projects, with the opportunity to achieve challenging goals. The role is suited to those motivated to make vital contributions to the next generation of radiopharmaceutical drugs.


Key Accountabilities

• Development of PETNETs manufacturing and QC testing procedures according to assigned projects.


• Oversee the development and validation of manufacturing and QC processes for PET drugs as they are introduced to PETNET.


• Lead development efforts to streamline, optimize, and scale up manufacturing and QC processes.


• Ensure the development work and validation is executed in compliance with GMP requirements .


• Facilitate the technical relationship with third party customers while onboarding new biomarkers.


• Contribute to the creation of SOPs for manufacturing and QC procedures.


• Support regulatory filings for the CMC sections of INDs and/or NDAs for PETNET and IP Sponsors.


• Lead development efforts to streamline, optimize, and scale up manufacturing and QC processes.


• Provide technical support to other PETNET engineering teams for all biomarkers.

Position Requirements


Education and Experience:

• Degree requirement is a PhD degree plus 4 years of experience, or Master's degree plus 6 years of experience.


• Practical radiochemistry or analytical validation experience is required.


• Experience developing or validating HPLC, TLC, or GC quality control methods required.


• Experience working in a GMP compliant manufacturing facility in PET (21 CFR 212) or pharmaceutical facility (21 CRF 211).


• Working knowledge of USP and EP.


• Strong written and verbal skills required.

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.


How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://jobs.siemens-healthineers.com/careers


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