Associate Specialist Manufacturing
- Hamilton, ON, Canada
- Canada – Hamilton – Longwood Road South, Canada
Full-time
Applications open in a new tab.
Job details
- Job type
- Full-time
- Apply by
- Experience
- 2-4 years of experience in a GMP manufacturing environment and cleanroom operations (sterile manufacturing) is required.
- Posting language
- English
- Posted
Original job description
Job Title: Associate Specialist Manufacturing
Location: Hamilton, Ontario
Onsite 5 days/week
Description:
Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radioconjugates that deliver powerful alpha‑emitting payloads directly to tumors. Our pipeline spans multiple first‑in‑class programs - backed by a GMP‑compliant, brand new radiopharmaceutical facility in Hamilton, we’re turning groundbreaking science into real‑world impact for patients. Join us at the forefront of radiopharma innovation and be part of turning breakthrough science into meaningful outcomes for patients - come build what’s next with us!
The Role:
The Associate Specialist Manufacturing plays a key role in the production of Fusion Pharma’s radiopharmaceutical products at its Hamilton, Ontario facility. Working within an aseptic manufacturing environment, this position supports the end-to-end process - from material preparation and radiopharmaceutical dispensing through patient dose packaging - while maintaining strict GxP, EHS, and radiation safety standards. The role also contributes to equipment calibration, cleaning and clearance activities, documentation, troubleshooting, inventory control, and continuous compliance across manufacturing operations.
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.
Qualifications:
- 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 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.
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
- View our YouTube channel
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.
⠀
Annual base salary for this position ranges from 67,944.00 to 89,176.50.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.
More about this job
Responsibilities
Manufacture and dispense radiopharmaceuticals in an aseptic environment, from material preparation through patient-dose packaging, while maintaining accurate production records and complying with GxP, EHS, and radiation safety requirements. Perform cleaning, clearance, calibration, troubleshooting, and investigation activities, and support packaging, receiving, and inventory control.
Requirements
A post-secondary degree in a life-science field and 2–4 years of GMP manufacturing and cleanroom experience are required, with sterile injectable experience essential. Environmental monitoring experience is an asset; radiopharmaceutical manufacturing and radiation safety training are preferred, along with strong computer, communication, organization, and problem-solving skills.
Skills
- Aseptic Manufacturing
- Sterile Manufacturing
- Radiopharmaceutical Manufacturing
- GMP Compliance
- Radiation Safety
- Environmental Monitoring
- Equipment Calibration
- Cleanroom Operations
- Troubleshooting
- Root Cause Analysis
- Inventory Control
- Documentation
- MS Office
- Cross-Functional Communication
- Prioritization
- Attention to Detail
Benefits
- Variable Pay Bonus
- Equity-Based Long-Term Incentive Program
- Flexible Benefits Program
- Retirement Savings Program
- Four Weeks' Paid Vacation
- Annual Personal Days
Visa sponsorship
Not detected in the job text
Categories
- Manufacturing
- Healthcare
- Science & Research
- Security & Safety
Keywords
- Radiopharmaceuticals
- Precision Oncology
- Radioconjugates
- Alpha-Emitting Payloads
- GMP
- GxP
- Aseptic Manufacturing
- Sterile Injectable Manufacturing
- Cleanroom Operations
- Environmental Monitoring
- Radiation Safety
- EHS
- Material Preparation
- Radiopharmaceutical Dispensing
- Patient Dose Packaging
- Production Records
- Isolator Cleaning
- Cleanroom Clearance
- Equipment Calibration
- Process Troubleshooting
- Investigations
- Root Cause Analysis
- Inventory Control
- Material Receiving
- Secondary Packaging
- Tertiary Packaging
- MS Office
- Computerized Systems