Microbiology Lead at JMD Technologies Inc. in Winthrop, Massachusetts

Microbiology Lead

We are seeking a Senior QC Microbiology professional to provide technical leadership and subject matter expertise supporting Environmental Monitoring (EM) and Utilities Monitoring (UM) within a GMP Cell & Gene Therapy manufacturing environment. This position supports microbiological testing, contamination control, aseptic processing, investigations, technical writing, and continuous improvement while partnering closely with Manufacturing, Quality Assurance, and Analytical Development teams.

Serve as SME for:

• Environmental Monitoring (EM)
• Utilities Monitoring (UM)
• Support sampling, testing, and contamination control programs
• Analyze EM/UM trends and recommend process improvements
• Support EM/UM trend reports and technical documentation

Support microbiological testing including:

• Sterility
• Endotoxin
• Bioburden
• Gram Stain
• Organism Identification

Operate and troubleshoot microbiology instrumentation including:

• Vitek
• Endosafe
• BacT
• MALDI-TOF
• Isolator

Lead and support:

• OOS investigations
• OOT investigations
• Deviations
• CAPAs
• Support laboratory inspections and regulatory audits
• Ensure compliance with cGMP requirements

Provide technical guidance to EM/UM team members

Drive projects with minimal supervision

Support cross-functional teams including:

• Manufacturing
• QA
• Regulatory CMC
• Analytical Development
• Draft and revise reports, SOPs, and technical procedures

Education:

• Bachelor's Degree in:
• Microbiology
• Biological Sciences
• Related Scientific Discipline

Required Experience:

• 7+ years of QC Microbiology experience
• Biotechnology and/or Cell & Gene Therapy industry experience
• Environmental Monitoring (EM)
• Utilities Monitoring (UM)
• Hands-on aseptic processing
• GMP laboratory experience
• LIMS experience
• Veeva Quality Management System experience
• Technical writing experience
• Scientific report writing
• Technical Knowledge:
• Strong understanding of:
• Environmental Monitoring
• Utilities Monitoring
• Sterility Testing
• Endotoxin Testing
• Bioburden
• APS / PAQ
• Contamination Control
• Microbiology investigations

• Cell & Gene Therapy experience
• Biopharmaceutical manufacturing
• Trend reporting
• Assay familiarity
• CAPA management
• OOS / OOT investigations
• Laboratory audit support

• $60-65/hr W2
• Duration: 12+ Months
• Location:
  
  Boston, MA 100% Onsite