Environmental Monitoring & Microbiology Manager

SOFIE; Totowa (NJ); On-site; USD 110,000 - 120,000; Full time

Job summary

SOFIE in Totowa, NJ, seeks a Manager – Microbiology & Environmental Monitoring to lead EM and sterility programs at the NJ5 site. You will oversee sampling, testing, trend reporting and qualification activities, ensuring robust microbiology control for GMP production.

The role requires 7–9+ years in cGMP microbiology with supervisory experience, ISO 7/5 access control, and strong regulatory knowledge to guide investigations and CAPAs. Competitive compensation and growth opportunities are offered.

Qualifications

• Bachelor’s degree in Life Science or related field with 7–9+ years in cGMP microbiology/production.
• Master’s degree in Life Science is a plus with 5–7+ years of experience.
• Supervisory experience and strong regulatory/compliance understanding.

Responsibilities

• Lead EM and sterility programs, including sampling, testing and trend reporting.
• Develop KPI for safety, quality and deliverables for the EM team.
• Oversee personnel, resource planning and performance reviews.
• Manage internal and external microbiology testing and subcontractors.
• Ensure ISO 7/ISO 5 access controls and aseptic practices compliance.

Skills

Leadership

Communication

Regulatory knowledge

Problem solving

MS Office

Team management

Education

Bachelor's degree in Life Science

Master's degree in Life Science

Tools

LIMS

GMP knowledge

Job description

SOFIE in Totowa, NJ, seeks a Manager – Microbiology & Environmental Monitoring to lead EM and sterility programs at the NJ5 site. You will oversee sampling, testing, trend reporting and qualification activities, ensuring robust microbiology control for GMP production.

The role requires 7–9+ years in cGMP microbiology with supervisory experience, ISO 7/5 access control, and strong regulatory knowledge to guide investigations and CAPAs. Competitive compensation and growth opportunities are offered.