Production Operator

Fusion Pharmaceuticals; Hamilton; On-site; CAD 45,000 - 60,000; Full time

Job summary

A leading company in oncology is seeking a Production Operator in Hamilton, ON. The role involves aseptic manufacturing of radiopharmaceuticals, maintaining compliance with GxP and EHS practices, and ensuring quality control in a fast-paced environment. Ideal candidates will have a life-science degree and experience in GMP settings.

Qualifications

• 2-4 years of experience in a GMP manufacturing environment.
• Experience with environmental monitoring programs is an asset.

Responsibilities

• Maintain the manufacturing area in aseptic conditions.
• Perform the manufacturing and dispensing of radiopharmaceuticals.
• Keep accurate records within the production records book.

Skills

Detail-oriented

Collaborative

Leadership

Education

Post secondary degree in life-science

Tools

MS Office Suite

Job description

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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.

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

The Manufacturing Technician 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

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

Requirements

1. Post secondary degree in life-science (chemistry, biology, biochemistry).
2. 2-4 years of experience in a GMP manufacturing environment and cleanroom operations (sterile manufacturing) is required.
3. Experience with environmental monitoring programs is an asset.
4. Proven experience in Sterile, injectable is a must; radiopharmaceuticals manufacturing and radiation safety training is preferred.
5. Efficient in the use of MS Office Suite and computerized systems required.
6. Ability to be detail-oriented, efficient, and collaborative with minimal 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.
7. Able to communicate/coordinate effectively with cross functional departmental staff.
8. Ability to investigate issues, identify root causes analysis and define resolutions.
9. Ability to organize, prioritize and deliver tasks & projects with a sense of urgency.

Flexibility with work hours depending on production schedule.

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.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Management and Manufacturing