Fusion Pharmaceuticals
Pharmaceuticals
MicrobiologyLaboratorySupervisor—RadioConjugateLaboratory
Neural analysis suggests this role is
optimal for Supervisor candidates.
“Microbiology Laboratory Supervisor — Radio Conjugate Laboratory at Fusion Pharmaceuticals. Skills: Microbiological control, Aseptic manufacturing, Regulatory compliance, Radiopharmaceuticals. Lead microbiology team. Supervise daily lab operations”
Industry & Context.
Root cause analysis
Work extended shifts, Work weekends, Work holidays, After-hours support, On-site presence, <5% travel
What They're Looking For.
Must Have
Bachelor's degree in Microbiology, 5–8 years supervising laboratory teams, Hands-on environmental monitoring, Contamination control experience, Cleanroom operations experience, Regulatory compliance experience, Work in designated labs, Work in isolators/hot cells
Nice to Have
Experience in radiopharmaceutical environments
What You'll Do.
Lead microbiology team
Supervise daily lab operations
Drive continuous training
Oversee aseptic process design
Oversee aseptic process simulation
Establish environmental monitoring
Maintain environmental monitoring
Analyze environmental monitoring
Perform trend analysis
Conduct contamination risk assessments
Maintain Contamination Control Strategy
Monitor cleanroom operations
Ensure GMP compliance
Ensure best aseptic practices
Ensure effective microbiological controls
Act as SME for regulations
Lead contamination event investigations
Lead root cause analysis
Implement process improvements
Work with cross-functional teams
Oversee EM for radiopharmaceuticals
Oversee bioburden for radiopharmaceuticals
Oversee sterility assurance for radiopharmaceuticals
Advise on interventions in isolators/hot cells
Ensure contamination control solutions
Design sampling plans for radiopharmaceuticals
Supervise sampling plans for radiopharmaceuticals
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality; Engineering; Production; Validation
Full Job Description
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 has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet the demand for our growing pipeline of RCs. **Overview** The Microbiology Supervisor is responsible for leading and supervising all aspects of microbiological control in a regulated aseptic manufacturing environment, with a focus on sterile radiopharmaceutical products. This role combines technical microbiology expertise with hands-on supervisory responsibilities, ensuring robust contamination control, high-quality environmental monitoring, radiological controls and compliance with global regulatory standards (including EU Annex 1 and GMP). Other duties can be assigned as required. **Responsibilities** * Microbiology Leadership: Lead and mentor the microbiology team, supervising daily lab operations and resource planning to meet manufacturing and clinical/commercial supply timelines; manage workload and performance, and drive continuous training to maintain meticulous quality and compliance standards. * Aseptic Process & Risk Assessment: Oversee aseptic process design and simulation, risk assessments, evaluate changes, ensuring compliance with regulatory requirements. * Environmental Monitoring: Establish, maintain, and analyze environmental monitoring programs and EMPQ, perform trend analysis and conduct contamination risk assessments. * Contamination Control: Maintain the site’s Contamination Control Strategy (CCS), including cleanroom zoning, gowning, and disinfectant program
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