Senior Specialist, External Manufacturing

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radio conjugates (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 radio conjugate 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.

Job Description:

As the Sr. Specialist, External Manufacturing reports into the Senior Manager, External Manufacturing you will be responsible for supporting external manufacturing projects. This individual will facilitate scheduling meetings, follow up on project tasks, and track progress against key project milestones and KPI’s. This position is located onsite in Hamilton, Ontario, Canada.

Note: This is a 5 day/week on-site position.

Key Responsibilities:

• Collaborating with Contract Development Manufacturing Organizations (CDMOs), the internal manufacturing site, and Clinical Supply Chain team to ensure drug supply is delivered on time.
• Working with internal stakeholders to plan new material introduction activities within the master manufacturing schedule and providing regular updates on ongoing activities and project statuses.
• Support cross-functional planning and execution of tech transfer, scale-up, process characterization, and validation (PPQ/PV). Ensure equipment/facility readiness, comparability, and robust control strategies.
• Partner with QA to ensure GMP compliance, inspection readiness, data integrity, and robust deviation/CAPA and change control. Support internal and external audits and regulatory inspections. Assisting in outlining and drafting Standard Operating Procedures (SOPs) and Work Instructions for departmental activities.
• Support with financial management of invoice approval for payment.
• Performing other duties as required by the business.

Qualifications:

• Minimum BSc in chemistry, engineering, or health sciences.
• 3+ years of experience in manufacturing, supply chain management, or project management within the pharmaceutical or radiopharmaceutical industry.
• Strong organizational skills with a proven ability to manage multiple tasks and meet deadlines.
• Excellent communication and interpersonal skills to work collaboratively with internal and external stakeholders.
• Knowledge of GMP regulations and clinical drug supply processes is a strong asset.
• Detail-oriented with a proactive approach to problem-solving.
• Ability to work effectively in a fast-paced, multidisciplinary team environment.
• Willingness to take on new tasks and responsibilities as required.

Preferred Qualifications:

• MSc. In chemistry, engineering, or health sciences
• Experience with CDMOs and familiarity with external manufacturing processes
• Ability to communicate effectively in Mandarin

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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  View email address on careers.astrazeneca.com

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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.

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