Empowering Next Generation Radiotherapeutics
Hamilton, Ontario
AtomVie Global Radiopharma Inc. ("AtomVie"), incorporated in late 2021, is a global leading CDMO for the GMP manufacturing and distribution of clinical and commercial radiopharmaceuticals and the most recent spinout from the Centre for Probe Development and Commercialization (CPDC). AtomVie offers the full range of scientific, technical, regulatory, quality, logistics and business expertise combined with a specialized infrastructure for the development of your radiopharmaceuticals from Phase 1 to the commercial marketplace. With a state-of-the art purpose-built facility that will be operational in Q4 2025, AtomVie empowers the development of your radiotherapeutics. For more information about AtomVie, visit our website or contact: info@atomvie.com.
Hybrid · Hamilton
Lead the quality assurance program for radiopharmaceutical products, ensuring full compliance with Health Canada, FDA, and EMA regulations. Oversee drug development through commercialization, focusing on quality systems, batch release, and driving a culture of quality across the organization.
Hybrid · Hamilton
The Vice President of Quality is responsible for overseeing product quality, safety, and regulatory compliance across clinical and commercial manufacturing. This role leads the transition to a new facility, manages quality functions like QA and QC, and drives a world-class GMP quality culture.
On-site · Hamilton
Perform equipment qualification and validation activities including the execution of protocols for cleanrooms, isolators, and hot cells. Manage vendor programs, develop operating SOPs, and lead investigations into equipment deviations and non-conformances.
On-site · Hamilton
Manage and execute laboratory equipment qualifications, calibrations, and preventive maintenance programs in compliance with GMP practices. Coordinate third-party contractors and lead documentation activities including non-conformance reports, change controls, and CAPAs.
On-site · Hamilton
The CQV Specialist supports the Engineering department by executing equipment qualifications, calibrations, and documentation in compliance with GMP practices. This includes managing vendor certification programs and authoring non-conformance reports and CAPAs.
On-site · Hamilton
The role involves authoring, reviewing, and managing a wide range of GMP documentation including SOPs, batch records, and deviation reports. You will also support process development, validation, and technology transfer while ensuring compliance with regulatory standards.
On-site
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. About The Role The C…
On-site · Hamilton
Responsible for the final disposition of incoming materials and radiopharmaceutical drug product batches by reviewing documentation and ensuring cGMP compliance. The role involves managing deviations, participating in SOP revisions, supporting audits, and driving continuous improvement efforts.
On-site · Hamilton
The Microbiologist will conduct routine microbiological testing and ensure compliance with Health Canada GMP requirements. Responsibilities also include maintaining laboratory records, supporting investigations, and assisting in technical documentation.
On-site · Hamilton
The Technical Writer authors and edits technical documents, including SOPs and validation protocols, to support radiopharmaceutical manufacturing operations. They also coordinate QMS tasks and support continuous improvement projects to ensure regulatory compliance.
On-site · Hamilton
The role involves authoring and managing the full lifecycle of GMP technical documentation, including SOPs, batch records, and validation reports for radiopharmaceutical manufacturing. It also requires coordinating with cross-functional teams to ensure documentation aligns with regulatory requirements and client timelines.
On-site · Hamilton
The Production Technician supports the production team by maintaining GMP areas and performing routine cleaning and decontamination of aseptic suites. They are also responsible for packaging dangerous goods and managing radioactive waste according to safety protocols.
Hybrid · Hamilton
Lead the quality assurance program for radiopharmaceutical products, ensuring full compliance with Health Canada, FDA, and EMA regulations. Oversee drug development through commercialization with a focus on Quality Systems, batch release, and driving a culture of quality across the organization.
On-site · Hamilton
The CQV Specialist assists the Engineering department with laboratory equipment qualifications, calibrations, and documentation in compliance with GMP practices. This includes managing calibration programs, executing validation activities for HPLC and Gas Chromatography, and authoring non-conformance reports and CAPAs.
On-site · Hamilton
The Microbiologist performs routine microbiological testing, including sterility and bioburden tests, according to USP and EP standards. They are also responsible for environmental monitoring of cleanrooms and maintaining the laboratory in compliance with Health Canada GMPs.
On-site · Hamilton
Responsible for the final disposition of incoming materials and radiopharmaceutical drug product batches to ensure they meet specifications and cGMP requirements. This includes reviewing batch records, managing deviations, and acting as a liaison for client-related batch issues.
On-site · Hamilton
Perform quality control testing on finished drug products, raw materials, and in-process samples using analytical chemistry and microbiology techniques. Ensure all work adheres to GMP, SOPs, and Canadian Nuclear Safety Commission regulations while maintaining detailed technical documentation.
