Full-Time
Quality Assurance Specialist
Isotopia USA
51-200 employees
Produces radiopharmaceuticals for cancer theranostics
No salary listed
Westfield, IN, USA
In Person
Bachelor's
 QA & Testing (1) |
|---|
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- A bachelor's degree in the life sciences or another technical field is required.
- At least 5 years of experience working in a quality control or quality assurance position supporting Good Manufacturing Practice manufacturing is required.
- Strong attention to detail, organizational ability, and record-keeping skills are required.
- Effective communication and teamwork abilities focused on collaborative problem solving are required.
- Ability to work in a regulated, fast-paced environment while maintaining a high level of accuracy is required.
- Flexibility to work shifts or outside normal business hours to handle time-sensitive processes is required.
- Strong commitment to safety, ethical conduct, and regulatory compliance is required.
- Create, implement, and support a comprehensive Quality Management System.
- Participate in the qualification of key suppliers, including executing internal and external audits and assessments.
- Create and implement manufacturing-support processes for active drug substance, including issuing batch records and test records, releasing raw materials, reviewing batch records, and releasing finished drug products.
- Create and manage site training and development programs, including Good Manufacturing Practice and Good Distribution Practice training.
- Support critical manufacturing investigations, including out-of-specification results and manufacturing-process deviations.
- Support the preparation and submission of regulatory filings, agency responses, and supplements, including Food and Drug Administration deficiency resolution, annual reporting, and correspondence with regulatory agencies such as the Nuclear Regulatory Commission, Food and Drug Administration, and European Union.
- Execute other tasks as needed to support ongoing tasks and projects critical to the success of the site.
- Experience working in positron emission tomography drug or radiopharmaceutical manufacturing under 21 CFR 210, 211, and/or 212 current Good Manufacturing Practices.
- Strong understanding of Good Manufacturing Practice and radiation safety principles.
Isotopia USA develops radiopharmaceuticals for cancer care, pairing diagnostic imaging with targeted radiation therapy. Its products include Tb-161 and Lu-177 therapeutics, Isoportrace PSMA-11 for prostate imaging, PET/SPECT radiopharmacy products, and sterile lyophilized offerings plus CMO services. The science works by using radiopharmaceuticals that deliver radiation to tumors while imaging agents locate disease. It differentiates through a global, integrated supply chain with Lu-177 production in Israel and FDA-compliant production in the US to ensure quality and reliable supply; its goal is to improve diagnostic accuracy and treatment outcomes worldwide.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Alton, Illinois
Founded
2007
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Simplify's Take
What believers are saying
- Germany launch and Denmark authorization validate European commercialization momentum in 2025.
- 2025-06-04 Gd-160 supply deal supports Tb-161 scale-up for targeted radiotherapeutics.
- 30,000-square-foot Indiana facility and 200,000-dose capacity support large-scale radiopharmaceutical manufacturing.
What critics are saying
- Westfield commercial production slipped from Q3 2025 guidance; execution risk remains severe.
- Isotopia still depends on a narrow isotope portfolio, exposing it to single-product demand shocks.
- ASP Isotopes supply begins in 2026; any precursor disruption hits Tb-161 commercialization quickly.
What makes Isotopia USA unique
- Isotopia runs Westfield, Indiana GMP lines for Lu-177 and Tb-161.
- Isotopia launched Isoprotrace in Germany on 2025-03-10 with DSD Pharma distribution.
- Isotopia secured Denmark authorization on 2025-02-19, expanding prostate imaging access across Europe.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
Paid Vacation
Paid Sick Leave
Paid Holidays
Professional Development Budget
Company News
PETAH TIKVA, Israel, April 10, 2025 /PRNewswire/ -- Isotopia Molecular Imaging is proud to announce the official launch of Isoprotrace®, its advanced Gallium-68 Gozetotide preparation kit for prostate cancer imaging, in the United Kingdom.This milestone underscores Isotopia's profound commitment to expanding access to high-quality diagnostic tools and improving patient care globally.Isoprotrace® is an innovative PSMA-11 (Gozetotide) radiolabelling kit designed to enhance the precision of prostate cancer imaging. The ready-to-use, multi-dose kit facilitates the efficient preparation of Gallium-68 Gozetotide solution for intravenous injection, equipping healthcare providers with a critical tool for diagnosing prostate cancer and optimizing treatment plans.Through a strategic partnership with Light Medical, Isotopia guarantees that Isoprotrace® will be readily available to medical facilities across the UK, thereby empowering clinicians to effectively detect and manage prostate cancer."The launch of Isoprotrace® in the United Kingdom represents a significant milestone in our mission to expand patient access to cutting-edge diagnostic solutions," said Tzachi Levy, General Manager of Isotopia's aseptic plant. "With the increasing demand for precision imaging in prostate cancer care," continued Mr. Levy, "Isoprotrace® offers healthcare professionals an essential tool to improve diagnostic accuracy and enhance treatment outcomes."Mark Goodwin, Director at Light Medical, added, "We are honored to collaborate with Isotopia in introducing Isoprotrace® to the UK market. This launch marks a vital step forward in combating prostate cancer, and we are committed to ensuring widespread availability of this innovative diagnostic kit for healthcare providers nationwide."Isotopia remains dedicated to maintaining a robust supply chain, thus ensuring seamless access to this essential diagnostic tool for healthcare providers and patients worldwide.For more information about Isoprotrace®, including product specifications and availability, please visit https://isotopia-global.com/isoprotrace/About Isotopia Molecular ImagingIsotopia Molecular Imaging is a global leader in radiopharmaceutical development, specializing in theranostic solutions that enhance diagnostic accuracy and treatment efficacy. With a steadfast commitment to innovation and patient-centred care, Isotopia delivers reliable, high-quality radiopharmaceuticals to healthcare providers worldwide.https://isotopia-global.com/isoprotrace/About Light MedicalLight Medical is a trusted distributor of advanced medical imaging solutions, dedicated to supporting healthcare professionals in delivering superior diagnostic and treatment options
Isotopia announces official commercial launch of Isoprotrace(R) in Germany in partnership with DSD Pharma.
Isotopia Molecular Imaging Ltd is thrilled to announce that Isoprotrace(R) | has received marketing authorization in the Netherlands RVG 130527.
Isotopia USA partners with E solutions to build its GMP manufacturing center.
Isotopia USA has chosen E Solutions to design and build its state-of-the-art GMP manufacturing centre.