Senior Chemist, Quality Control

at  Fusion Pharmaceuticals US Inc

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals 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; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.

POSITION SUMMARY:

Fusion has opened the role of Senior 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.

QUALIFICATIONS:

• Bachelor’s degree or equivalent experience.
• 4+ 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, and/or Biology tests such as IRF, ELISA.
• Proficiency with equipment data processing software such as Empower (HPLC, GC).
• 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 aseptic operations (use of a BSC - Biological Safety Cabinet) and 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.

• Validate/transfer and document new analytical methods with minimum supervision. Independently prepare validation/transfer protocols, reports according to regulatory guidelines (ICH, USP, EP etc.).
• Perform quality control (release & retrospective) testing of drug materials and finished drug products according to test methods, including analytical chemistry, biological and microbiological tests and other tests according to the USP, EP.
• 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.
• Conduct all work in accordance with Fusion Standard Operating Procedures (SOPs)/Work Instructions (WIs) and raise any deviations immediately to the attention of Lab Management and Quality Assurance.
• Conduct investigations for testing failure and non-conformances and implement corrective actions.
• Adhere to GxP 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 GxP 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.
• Conduct peer review of laboratory records and QC document, create the release certificate of analysis.
• Author new test methods, controlled forms, data entry templates, etc. Prepare change control proposal and revise/improve existing test methods.
• Write technical documents (e.g., author/create specifications, test reports, data summaries, investigations, CAPAs); prepare CAPA implementation plans and participate in closing laboratory investigations.
• Responsible for training other colleagues, colleagues from other departments.
• 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).
• Work as a member of a team to achieve all outcomes; Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.