![AtomVie Global Radiopharma Inc.](https://media.trabajo.org/img/noimg.jpg)
PhD Scientist
1 week ago
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.
Are you passionate about science and chemistry? Do you thrive on tackling complex challenges and want to make a real impact in the field of radiopharmaceuticals? As an Analytical Scientist, will be an expert in the areas of analytical test method development, transfer, and validation. They will provide technical leadership and project management support accross Analytical Development, Production and QA teams at AtomVie. The incumbent establishes work schedules and assignments to ensure the successful completion of tasks while ensuring consistent high quality.
Lead development projects, prepare presentations, attend client meetings, and provide expert technical advice to clients.
Plan, implement and successfully complete assigned Analytical Development (AD) projects (e.g., method development, transfer, validation activities, and related tasks) while ensuring consistent high quality and compliance with cGMP.
Responsible for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.)
Write test reports, data summaries, and statistical evaluations/trending.
Conduct review of Analytical Development laboratory records / notebooks.
Assist in the management of third-party analytical testing service providers.
Conduct all work in accordance with AtomVie SOPs and raise any deviations immediately to the attention of Management
Perform quality control \ testing of incoming materials, drug substances and finished drug products according to standard testing methods.
Perform peer/technical review of QC data.
Perform routine quality operations including technical document review, calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required.
Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety.
Office and ability to write technical documents and reports.
Ability to work in a facility that handles radioisotopes and radiopharmaceuticals.
D. in Chemistry, Chemical Biology, Biotechnology or a related discipline.
~10 + years’ hands-on experience in a pharmaceutical GMP environment, specifically in laboratory sample preparation techniques, operation of HPLC, GC, and TLC, and method transfer, development and validation.
~ Knowledge and experience in UV, IR, mass spectrometry and NMR, microbiological release testing of pharmaceuticals (e.g. Bioburden, Sterility, and Bacterial Endotoxins) and testing of biologicals are assets.
Group Health & Dental Benefits (from day 1)
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.
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