Analytical Development and Validation Specialist
1 week ago
We are seeking a highly skilled and experienced Senior Analytical Chemist to join our team at AtomVie Global Radiopharma Inc. As a key member of our Analytical Development and Quality Control team, you will be responsible for ensuring the quality and integrity of our pharmaceutical products.
Key Responsibilities- Develop and validate analytical methods for quality control testing of pharmaceutical drug products
- Provide technical leadership and project management support to the Analytical Development, Production, and QA teams
- Establish work schedules and monitor assignments to ensure timely completion of tasks and consistent high quality
- Conduct analytical method development, transfer, and validation activities, including defining comprehensive validation procedures and performing routine and complex validation activities
- Provide analytical support for process development, including characterization of starting materials, intermediates, API, and finished products
- Perform structure elucidation of unknown impurities/degradation products and 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.)
- Act as point of contact for other departments and team members for matters related to method development and validation
- Prepare presentations for client review to summarize results and project status updates and participate in client meetings
- Perform troubleshooting and investigations in cross-functional teams in support of AD, QC, QA, and other departments
- Perform quality control (release & retrospective) testing of incoming materials, drug substances, and finished drug products according to standard testing methods (STMs)
- 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
- Troubleshoot systems and provide guidance and mentoring to others
- 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
- Work as a member of a team to achieve all outcomes; ensure that daily work activities are aligned with a production and stability plan/calendar, and work with management to accommodate last-minute changes or absences
- 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
- Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals
- Complete all other related duties, as required
- Experience in QC testing of materials and products using HPLC, GC, TLC, etc.
- Proficiency in performing HPLC and GC method development and validation, including thorough documentation of such studies
- Skilled in data interpretation of UV, IR, MS, and NMR spectra
- Expertise in working with antibodies, proteins, and antibody-drug conjugates, including protein characterization, UV/VIS, etc., 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
- Proficiency in using spreadsheets (e.g., 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
- Requirements: Degree in Chemistry, Biological Chemistry, or Biotechnology; M.Sc. or Ph.D. is preferred; 8+ years' hands-on experience in a pharmaceutical GMP environment; hands-on experience with developing new analytical methods and validation
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Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full timeAbout the RoleWe are seeking a highly skilled Senior Analytical Chemist to join our team at AtomVie Global Radiopharma Inc. as a key member of our Analytical Development and Quality Control department.Key ResponsibilitiesPlan, implement, and successfully complete assigned Analytical Development and Quality Control projects and tasks in a timely fashion while...
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Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full timeAbout the RoleWe are seeking a highly skilled Senior Analytical Chemist to join our team at AtomVie Global Radiopharma Inc. as a key member of our Analytical Development and Quality Control department.Key ResponsibilitiesPlan, implement, and successfully complete assigned Analytical Development and Quality Control projects and tasks in a timely fashion while...
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