Microbiology Lead
JMD Technologies Inc.
Title: Microbiology Lead
Location: Boston, MA (100% Onsite)
Employment Type: Contract (12+ Months)
Status: Accepting Candidates
About the Role
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
Qualifications
- 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
Compensation
- $60–65/hr W2
- Duration: 12+ Months
- Location: Boston, MA 100% Onsite
Vacancy posted 17 hours ago
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