Production Operator

6 months ago

Hamilton, Canada Fusion Pharmaceuticals US Inc Full time

**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; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), 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.

Fusion’s radiopharmaceuticals manufacturing facility is the first of its kind for the production of targeted alpha therapy agents.

The Production Operator is responsible for performing tasks involved in the dose manufacturing of Fusion’s radiopharmaceuticals products.

This position reports to the Associate Director, Radiopharmaceuticals Manufacturing Operations, and is based in Hamilton, ON.

**Responsibilities**:

- Work with the operations team to maintain the manufacturing area in aseptic conditions.
- Perform the manufacturing and dispensing of radiopharmaceuticals compounds, in an aseptic environment, from material picking to patient dose packaging.
- Keep accurate records within the production records book.
- Perform the isolator and laboratory periodic cleaning activities prior to initiate a production campaign.
- Perform the line and cleanroom clearance after a production run.
- Assist during the process troubleshooting and investigation activities.
- Perform the periodic calibration of manufacturing equipment(s).
- Adhere to the GxP, EHS and radiation safety practices, maintain excellent training and performance records.
- Assist the team during secondary and tertiary packaging, material receiving and inventory control activities.

**Requirements**:

- Post secondary degree in life-science (chemistry, biology, biochemistry).
- 2-4 years of experience in a GMP manufacturing environment and cleanroom operations (sterile manufacturing) is required.
- Experience with environmental monitoring programs is an asset.
- Proven experience in Sterile, injectable is a must, radiopharmaceuticals manufacturing and radiation safety training is preferred.
- Efficient in the use of MS Office Suite and computerized systems required.
- Ability to be detail-oriented, efficient, and collaborative with mínimal supervision is required. Motivation and leadership skills, with strong work ethic, integrity, and stability in the workplace and ability to thrive in a fast-paced environment.
- Able to communicate/coordinate effectively with cross functional departmental staff.
- Ability to investigate issues, identify root causes analysis and define resolutions.
- Ability to organize, prioritize and deliver tasks & projects with a sense of urgency.

Flexibility with work hours depending on production schedule.

Fusion Requires all employees to be current with their COVID vaccination requirements.

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.

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