Microbiology Technician

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 but is not limited to: 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-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. Fusion has multiple other pipeline programs that will soon be entering into early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet supply demand for our growing pipeline of RCs.

Position Summary

Fusion has opened a newly created role within Quality Assurance, Microbiology for a Microbiology Technician. This position will focus on GxP compliance within the Fusion manufacturing facility supporting sterility assurance of the cleanroom environment. This role will be responsible for execution of the environmental monitoring program, microbial analysis, and validation support. This role will report to the Manager of Microbiology.

Occasional weekend work may be required with advanced notice.

Responsibilities

• Environmental Monitoring: Conducting Environmental Monitoring of cleanrooms and supporting critical controlled areas in the manufacturing facility.
• Microbial testing and Quality Control: Incubation and inspection of sterility samples, enumeration of media from environmental monitoring, bioburden testing, microbial identification. Support validation activities in the manufacturing facility and the microbiology laboratory.
• Sterility Assurance: Maintaining good aseptic techniques and working in compliance with Biosafety regulations. Support training on gowning techniques and aseptic behaviour in cleanrooms.
• Laboratory Housekeeping: Day-to-day activities related to general housekeeping of the CL2 Microbiology laboratory. Collaborate cross functionally to ensure scheduling of sample collection and analysis. Maintain media and reagents inventory as needed for microbiological testing. Support equipment maintenance.
• Maintain accurate laboratory records and data. Record and share information in an open, and timely manner, following GxP procedures.
• Assisting with managing priorities and schedule such that individual goals as well as team goals are achieved.
• Responsible for the completion of required training.
• Works with biohazardous and radioactive materials.

Qualifications

• Minimum of 1 - 3 years of previous GxP experience, experience in environmental monitoring / cleanrooms strongly preferred.
• Bachelor's degree, preferably in a biological science field, such as biology, microbiology, biotechnology, or equivalent.
• Strong technical background with previous experience working in pharmaceutical industry is preferred.
• Strong written and verbal communication skills.
• Proficient in MS Word and Excel.
• Understanding of GxP regulations including GMP, GDP.

Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes. If contacted for an interview, please advise Human Resources if you require accommodation.

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