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Microbiology Lead at JMD Technologies Inc. in Dorchester, Massachusetts
Job in
Dorchester Center, Suffolk County, Massachusetts, 02124, USA
Listed on 2026-07-05
Listing for:
JMD Technologies Inc.
Full Time
position Listed on 2026-07-05
Job specializations:
-
Healthcare
Medical Science, Data Scientist -
Quality Assurance - QA/QC
Job Description & How to Apply Below
Location: Dorchester Center
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.
Key Responsibilities- Environmental & Utilities Monitoring
- 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
- QC Microbiology
- Support microbiological testing including:
- Sterility
- Endotoxin
- Bioburden
- Gram Stain
- Organism Identification
- Operate and troubleshoot microbiology instrumentation including:
- Vitek
- Endosafe
- BacT
- MALDI-TOF
- Isolator
- Investigations & Quality Systems
- Lead and support:
- OOS investigations
- OOT investigations
- Deviations
- CAPAs
- Support laboratory inspections and regulatory audits
- Ensure compliance with cGMP requirements
- Technical Leadership
- 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
- Preferred Qualifications
- 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
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