Senior QC Microbiology SME – EM/UM & Contamination Control

Atrium; Boston (MA); On-site; USD 90,000 - 99,000; Full time

Job summary

Vertex Pharmaceuticals in Boston, MA seeks an Environmental Monitoring and Utilities Monitoring Technical Support SME to provide expert microbiology support within QC. The role focuses on EM/UM sampling, testing, aseptic processing and contamination control under regulatory standards.

Reports to Associate Director of QC in Cell and Gene Therapies. The candidate will guide EM/UM analysts, handle OOS/OOT investigations, CAPA, audits, and cross-functional collaboration across Manufacturing, QA,

Qualifications

• Bachelor's degree in Microbiology or related field required.
• 7+ years of industry Microbiology experience in biotech/cell and gene therapy.
• Strong knowledge of QMS and regulatory standards.

Responsibilities

• Provide SME-level technical support for EM/UM, including sampling and microbiological testing.
• Guide investigations of OOS and OOT; manage CAPA for microbiological methods.
• Support cGMP compliance, audits, and inspections; communicate with cross-functional teams.

Skills

Microbiology expertise

cGMP knowledge

Quality Control

Scientific writing

LIMS experience

Education

Bachelor's degree in Microbiology

Tools

LIMS

Veeva

Job description

Vertex Pharmaceuticals in Boston, MA seeks an Environmental Monitoring and Utilities Monitoring Technical Support SME to provide expert microbiology support within QC. The role focuses on EM/UM sampling, testing, aseptic processing and contamination control under regulatory standards.

Reports to Associate Director of QC in Cell and Gene Therapies. The candidate will guide EM/UM analysts, handle OOS/OOT investigations, CAPA, audits, and cross-functional collaboration across Manufacturing, QA,