Analytical Scientist

at  AtomVie Global Radiopharma Inc

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.

REQUIREMENTS

• M.Sc. or Ph.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.

ABOUT THE ROLE

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? If you have a wealth of experience in the pharmaceutical industry and are looking for your next exciting opportunity, AtomVie is the place for you.
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.

WHAT YOU WILL DO

• 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.
• Provide analytical support for process development including characterization of starting materials, intermediates, API, and finished products.
• 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.
• Perform troubleshooting and investigations in cross-functional teams under the direction of management.
• 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.
• Write, revise, and review INVs, NCs, CAPAs.
• 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.
• Troubleshoot equipment systems (HPLCs, GCs, LSC, Gamma Counter, Gamma Spec, etc.).
• Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety.
• Ahere to Health Canada, GMP/GDP regulations and maintain compliance with Health, Safety and Environment protection rules
• Complete all other related duties, as required.

WHAT YOU BRING TO THE ROLE

• Working knowledge of GLP/GMP and applicable FDA, EMA, ICH, and EANM guidance documents.
• Good verbal and written communication skills, strong numeracy skills and the ability to work both independently and as part of the team
• Demonstrated ability to successfully organize, prioritize, manage time, multitask, and troubleshoot.
• Proficiency with spreadsheets and Ms. Office and ability to write technical documents and reports.
• Flexibility in work schedule to support a 24/7 production environment based on customer demand, including weekends.
• Ability to work in a facility that handles radioisotopes and radiopharmaceuticals.
• Capable of standing, walking, and/or sitting, for extended periods of time. Ability to lift 23 kilograms required.