Pharmaceutical Development Specialist

1 week ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

At AtomVie Global Radiopharma Inc., we are a leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals.

We strive to transform patients' lives by advancing high-quality drugs for the treatment and diagnosis of diseases. As a community, we challenge ourselves professionally, take pride in our accomplishments, and value the impact we make with our partners and patients worldwide.

We invite you to join our team as a Senior Analytical Chemist, an expert in quality control testing of pharmaceutical drug products. You will provide technical leadership and project management support to the Analytical Development, Production, and QA teams at AtomVie.

The Senior Analytical Chemist is responsible for establishing work schedules, monitoring assignments, and ensuring timely completion of tasks while maintaining consistent high quality. They will lead analytical method development, transfer, and validation activities, including defining comprehensive validation procedures and providing guidance to junior staff.

Key responsibilities include:

  • Planning, implementing, and completing assigned Analytical Development and Quality Control projects and tasks on time with consistent high quality.
  • Conducting analytical method development, transfer, and validation activities, including defining comprehensive validation procedures.
  • Performing routine and complex validation activities independently per approved protocols and guiding junior staff.
  • Providing analytical support for process development, including characterization of starting materials, intermediates, API, and finished products.
  • Performing structure elucidation of unknown impurities/degradation products.
  • Writing test reports, data summaries, and statistical evaluations/trending.
  • Initiating change controls to implement/revise/improve programs and methods and monitoring completion of all work in a timely fashion.
  • Writing, revising, and reviewing 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.
  • Acting as a point of contact for other departments and team members for matters related to method development and validation.
  • Preparing presentations for client review to summarize results and project status updates and participating in client meetings.
  • Performing troubleshooting and investigations in cross-functional teams in support of AD, QC, QA, and other departments.
  • Performing 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).
  • Coordinating 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.
  • Assisting QA in the management of third-party analytical testing service providers and vendor qualification.
  • Conducting investigations for testing failure and non-conformances and implementing corrective actions.
  • Writing technical documents; preparing CAPA implementation plans and taking an active role in closing laboratory investigations.
  • Responsible for training other colleagues, colleagues from other departments, and new staff in all department-related disciplines.
  • Performing routine quality operations, including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required.
  • Troubleshooting systems and providing 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.
  • Working as a member of a team to achieve all outcomes; ensuring that daily work activities are aligned with a production and stability plan/calendar, and working 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).
  • Adhering to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance.
  • Maintaining an up-to-date training record.
  • Understanding and working under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
  • Completing all other related duties, as required.

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