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Analytical Development and Quality Control Specialist
2 months ago
We 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 Responsibilities- Plan, implement, and successfully complete assigned Analytical Development and Quality Control projects and tasks in a timely fashion while ensuring consistent high quality.
- Conduct analytical method development, transfer, and validation activities, including defining comprehensive and complex validation procedures for all analytical methods based on scientific knowledge, experience, and support from subject matter experts.
- Perform routine and complex validation activities independently per approved protocols, and provide guidance and oversight to junior staff working on these 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.
- 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.) for review by management, QA, and/or customers.
- Act as a 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), including Chemical (e.g. HPLC Assay and Impurities, Radiochemical Purity, pH, iTLC, Residual solvents by GC).
- 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. Maintain an up-to-date training record.
- Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
- Complete all other related duties, as required.
- 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.
- Flexibility in work schedule to support a 7-day work week and manufacturing/client demand at varying times (early morning/late evening).
- Ability to lift 23 kilograms required.
- Group Health & Dental Benefits (from day 1)
- RRSP Matching Program
- Perkopolis
- Employee Assistance and Wellness Programs
- Parking Allowance
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
