Chemist, Quality Control

at  Fusion Pharmaceuticals US Inc

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion’s growing pipeline of RCs.
Position Summary:
Fusion has opened the role of Chemist, Quality Control. The successful candidate will be responsible for performing QC (release & retrospective) testing according to the test methods, routine quality operations, investigations for testing failure, non-conformances and implement corrective actions; technical review of Lab records and QC documents, authoring QC documents like methods, controlled forms, investigations, CAPAs, preparing change control proposals; independently preparing validation/transfer protocols, reports, performing method transfers or method validations; providing training to colleagues. The role will report to the Manager, Quality Control.

Key Responsibilities:

• Perform quality control (release & retrospective) testing of finished drug products and drug materials according to testing methods (TMs), including analytical chemistry, and microbiological tests and other tests according to the USP, EP, BP.
• Support method development, transfer, and validation activities. Perform validation/transfer activities independently with guidance as per approved protocols.
• Write new test methods, SOPs, controlled forms, data entry templates, etc. Prepare validation protocols with input from SMEs. Author validation reports according to regulatory guidelines (ICH, USP, EP, etc.) with inputs from SMEs.
• Conduct technical (peer) review of laboratory records; Write technical documents (specifications, test reports, data summaries, investigations, deviation, CAPAs). Prepare CAPA implementation plans and participate in closing laboratory investigations.
• Conduct investigations for testing failure and non-conformances and implement corrective actions. Prepare CAPA implementation plans and participate in closing laboratory investigations.
• Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures, analytical reagents, and consumables when required.
• Conduct the housekeeping of the facility including the disposal of hazardous waste (radioactive and chemical) 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.
• Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• 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.
• Understand and work under the Canadian Nuclear Safety Commission regulations.
• Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
• Provide training to other colleagues, colleagues from other departments.

Qualifications:

• Bachelor’s degree or equivalent experience.
• 2+ years of related experience in in a pharmaceutical GxP environment, performing analytical chemistry techniques such as HPLC, GC and TLC, microbiology tests such as Bacterial Endotoxins.
• Proficiency with equipment data processing software such as Empower (HPLC, GC), ICP-MS MassHunter (ICP-MS).
• Proficiency with spreadsheets (e.g., Excel, Google Sheets), word processing software (e.g., Word) and ability to write technical documents and reports.
• Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
• Experience in working under Canadian Nuclear Safety Commission regulations are assets in this role.
• Ability to lift and move heavy weights up to 23 kilograms is required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.

• Perform quality control (release & retrospective) testing of finished drug products and drug materials according to testing methods (TMs), including analytical chemistry, and microbiological tests and other tests according to the USP, EP, BP.
• Support method development, transfer, and validation activities. Perform validation/transfer activities independently with guidance as per approved protocols.
• Write new test methods, SOPs, controlled forms, data entry templates, etc. Prepare validation protocols with input from SMEs. Author validation reports according to regulatory guidelines (ICH, USP, EP, etc.) with inputs from SMEs.
• Conduct technical (peer) review of laboratory records; Write technical documents (specifications, test reports, data summaries, investigations, deviation, CAPAs). Prepare CAPA implementation plans and participate in closing laboratory investigations.
• Conduct investigations for testing failure and non-conformances and implement corrective actions. Prepare CAPA implementation plans and participate in closing laboratory investigations.
• Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures, analytical reagents, and consumables when required.
• Conduct the housekeeping of the facility including the disposal of hazardous waste (radioactive and chemical) 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.
• Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• 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.
• Understand and work under the Canadian Nuclear Safety Commission regulations.
• Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
• Provide training to other colleagues, colleagues from other departments