Senior QC Microbiology Lead — EM/UM Specialist

Vertex Pharmaceuticals LLC; Boston (MA); In loco; USD 90.000 - 99.000; Tempo pieno

Descrizione del lavoro

Vertex Pharmaceuticals LLC seeks an Environmental Monitoring and Utilities Monitoring Technical Support SME to provide expert technical guidance in EM/UM sampling, testing, aseptic processing, and contamination control. The role reports to the Associate Director of Quality Control in Cell and Genetic Therapies.

You will support cross‑functional teams, handle OOS/OOT investigations, CAPA implementation, and assist with inspections while ensuring compliance with cGMP and Vertex standards.

Competenze

• Bachelor’s degree in Microbiology or related field.
• 7+ years of industry microbiology experience in biotech/cell and gene therapy.

Mansioni

• Provide SME-level technical support for EM/UM sampling, testing, aseptic processing, and contamination control.
• Ensure cGMP compliance and Health, Safety, Environmental policies.
• Support investigations (OOS/OOT) and CAPA.
• Assist with inspections, audits, and follow-up actions.
• Draft EM/UM trend reports and revise related documents.
• Collaborate with Manufacturing, QA, Regulatory CMC, and Analytical Dev teams.

Conoscenze

Environmental Monitoring

Microbiology testing

cGMP compliance

Regulatory knowledge

Project management

Scientific writing

Cross-functional collaboration

Formazione

Bachelor’s degree in Microbiology

7+ years industry experience in Microbiology

Strumenti

LIMS

Quality Management System – Veeva

Descrizione del lavoro

Vertex Pharmaceuticals LLC seeks an Environmental Monitoring and Utilities Monitoring Technical Support SME to provide expert technical guidance in EM/UM sampling, testing, aseptic processing, and contamination control. The role reports to the Associate Director of Quality Control in Cell and Genetic Therapies.

You will support cross‑functional teams, handle OOS/OOT investigations, CAPA implementation, and assist with inspections while ensuring compliance with cGMP and Vertex standards.