CMC Project Manager

AstraZeneca • Hamilton, ON

2d • $122,635 - $160,959

About The Position

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. The incumbent will be responsible to coordinate the cross-functional planning and operations of multiple projects within manufacturing, manage timelines, and mitigate risk to ensure successful delivery of team goals. This role will report to the Director, Technical Operations. The successful candidate must have excellent project management skills, a strong engineering background and experience with manufacture of investigational products.

Requirements

• 3+ years experience in product development and manufacturing
• Advanced degree in Chemical/Pharmaceutical Engineering, Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline preferred.
• PMP certification preferred.
• Experience with investigational product manufacturing (early phase to commercial).
• Strong project management and organizational skills.
• Experience with external manufacturing oversite.
• Experience with analytical method development and validation desirable.
• Excellent interpersonal skills that lead to successful collaborative working relationships. with key colleagues across the organization.
• Ability to work independently.
• Strong leadership skills, demonstrated ability to exercise sound judgment on key technical issue.

Responsibilities

• Plan, initiate and execute new or existing projects within Technical Operations and cross-functionally.
• Build and maintain detailed Gantt charts that illustrate complex interdependencies and project timelines.
• Lead recurring team meetings by developing structured agendas, facilitating discussions and distributing meeting minutes.
• Coordinate and track activities across multiple projects both internally and with external manufacturing partners.
• Identify risks and develop mitigation plans.
• Work with internal and external resources on implementation.
• Collaborate with the radiopharmaceutical and quality teams on the introduction of new materials and processes into the clinical supply chain.
• Apply practical working knowledge and application of project management techniques and concepts to internal and external manufacturing initiatives.
• Provide updates on activities being coordinated to functional leadership verbally and via and via reports/dashboards.

Benefits

• Annual base salary for this position ranges from 122,635.20 to 160,958.70.
• Annual Variable Pay Bonus/Short Term Incentive opportunity
• Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
• Competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• annual Personal Days.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level