Lead Specialist Manufacturing

Job Title: Lead Specialist Manufacturing

Location: Hamilton, Ontario

Onsite 5 days/week

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 innovative radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs. 

Introduction to role

As the Lead Specialist, Manufacturing, you will execute end-to-end dose manufacturing and aseptic dispensing of sterile, injectable radiopharmaceutical products while upholding the highest GxP, EHS, and radiation safety standards. Reporting to the Associate Director, Radiopharmaceuticals Manufacturing Operations, you’ll lead by example on the production floor—maintaining aseptic conditions, performing line and cleanroom clearances, documenting with precision, supporting troubleshooting and investigations, and calibrating equipment to ensure reliable supply of patient-ready doses. You will also contribute to environmental controls, inventory and packaging workflows, and the training of new team members. This role is ideal for a detail-oriented GMP professional with sterile manufacturing experience who thrives in fast-paced, collaborative settings and is motivated to make a tangible impact on patients’ lives.

Accountabilities

• 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.
• Supports training of new team members.

Essential Skills/Experience

• Post secondary degree in life-science (chemistry, biology, biochemistry).
• 4-7 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 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.
• 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.

Why AstraZeneca:
At AstraZeneca, you will work where bold science meets practical impact—sitting alongside imaging specialists, clinicians, data scientists, and biologists to challenge assumptions and move at pace. Our pipeline is fueled by unparalleled data and an interdisciplinary approach that blends novel biomarkers, AI-enabled insights, and innovative endpoints to reimagine how cancer is treated. We value kindness alongside ambition and empower people to take smart risks, learn quickly, and see their ideas translate into real options for patients worldwide.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
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Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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Annual base salary for this position ranges from 82,524.00 to 108,312.75.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.