Senior Analytical Lab Chemist—
7 days 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.
Senior Analytical Chemist is an expert in quality control testing of pharmaceutical drug products and experienced in the areas of analytical test method development (HPLC, GC, etc.), They provide technical leadership and project management support to the Analytical Development, Production and QA teams at AtomVie. The incumbent establishes work schedules and monitors assignments to ensure the successful completion of tasks in a timely fashion while ensuring consistent high quality in a constant effort to provide best support to the organization with professionalism and integrity.
Plan, implement and successfully complete assigned Analytical Development and Quality Control projects and tasks in a timely fashion while ensuring consistent high quality.
Define comprehensive and complex validation procedures for all analytical methods based on scientific knowledge, experience and support from SMEs.
Perform routine and complex validation activities independently per approved protocols, and provide guidance and oversight to junior staff working on these activities
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, STMs, SOPs, specifications, change controls, etc. according to regulatory guidelines (ICH, USP, etc.) Prepare presentations for client review to summarize results and project status updates and participate in client meetings.
Perform quality control (release & retrospective) testing of incoming materials, drug substances, and finished drug products according to standard testing methods (STMs), including Chemical (e.g. Coordinate quality control (release &retrospective) testing of drug substances and raw materials with contract laboratories or contract research organizations according to standard testing procedures, USP or EP.
Assist QA in the management of third-party analytical testing service providers and vendor qualification.
Conduct investigations for testing failure and non-conformances and implement corrective actions.
Write technical documents; prepare CAPA implementation plans and take an active role in closing laboratory investigations.
Responsible for training other colleagues, colleagues from other departments, and new staff in all department related disciplines.
Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required. Responsible for new equipment purchases and installation.
Responsible for the housekeeping of the facility including the disposal of hazardous waste (chemical and radioactive) through the appropriate waste-streams.
Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).
Adhere to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance. Maintain an up-to-date training record.
Experience in QC testing of materials and products using HPLC, GC, TLC, etc.
Skilled in data interpretation of UV, IR, MS, and NMR spectra.
and proficiency in chemical analysis.
Experience with sterile products, a background in working in a BSL2 laboratory, and knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is considered an asset.
Excel, Google Sheets) with the ability to rapidly input data and retrieve records, statistics, trends, etc.
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.
Degree in Chemistry, Biological Chemistry or Biotechnology.
~ Flexibility in work schedule to support a 7-day work week and manufacturing/client demand at varying times (early morning/late evening).
~ 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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