Radiopharmaceutical Quality Control Specialist
2 weeks ago
AtomVie Global Radiopharma Inc. is a leading manufacturer and distributor of clinical and commercial radiopharmaceuticals, dedicated to transforming patients' lives through high-quality drugs for disease treatment and diagnosis. Our community thrives on professional challenges, takes pride in collective accomplishments, and values the impact made with partners and patients worldwide. Join us to start your career today and contribute to our vision: revolutionizing healthcare through life transformation.
About the RoleThe Senior Analytical Chemist serves as an expert in quality control testing of pharmaceutical drug products, bringing extensive experience in analytical test method development (HPLC, GC, etc.). This role provides technical leadership and project management support to the Analytical Development, Production, and QA teams at AtomVie. Key responsibilities include establishing work schedules, monitoring assignments, and ensuring timely task completion while maintaining consistent high quality. The incumbent must provide best support to the organization with professionalism and integrity.
- Plan, implement, and complete assigned projects and tasks in a timely manner while ensuring consistent high quality.
- Perform routine and complex validation activities independently according to approved protocols and provide guidance and oversight to junior staff.
- Write test reports, data summaries, and statistical evaluations/trending.
- Initiate change controls to implement/revise/improve programs and methods and monitor completion of all work in a timely fashion.
- Write, revise, and review technical documents, validation documents (protocols, reports), STMs, SOPs, specifications, change controls, etc., according to regulatory guidelines (ICH, USP, etc.).
To succeed in this role, you will need:
- Degree in Chemistry, Biological Chemistry, or Biotechnology.
- Experience in QC testing of materials and products using HPLC, GC, TLC, etc.
- Skill in data interpretation of UV, IR, MS, and NMR spectra.
- Background in working in a BSL2 laboratory and knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is considered an asset.
- Strong writing skills, including the ability to compose technical documents, reports, and presentations for customer meetings.
- Excellent communication skills in English, coupled with the ability to work both independently and collaboratively in a team environment.
We offer competitive compensation, Group Health & Dental Benefits from day one, and opportunities for growth and development within a dynamic organization 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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