QC Microbiology Leader: GMP & Regulatory Excellence

Scorpion Therapeutics; Hopewell (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in New Jersey seeks a Lead QC Microbiology professional to manage GMP environmental monitoring, materials testing, and finished product microbiology.

You will establish and qualify a new QC Microbiology lab, oversee investigations and CAPAs, mentor a team, and ensure compliance with FDA/EU regulations.

On-site role with ~10% travel, supporting commissioning of facilities and regulatory inspections.

Qualifications

• 8+ years in an FDA-regulated biopharma or biotech environment
• at least 5 years in team management
• expertise in pharmaceutical microbial testing, microbiology equipment, and regulations (USP/EP, cGMP/EU GMP)

Responsibilities

• Lead establishment and qualification of the new QC Microbiology lab
• Implement microbiology procedures
• Support commissioning of new facilities
• Participate in regulatory inspections
• Oversee routine testing, investigations, CAPAs, and microbial method verification
• Build and mentor a high-performing microbiology team
• Ensure compliance with FDA/EU regulations
• Optimize lab efficiency

Skills

Microbiology testing

GMP/CGMP

Team leadership

Regulatory compliance

Environmental monitoring

Education

Bachelor’s in science (microbiology, biotech, pharmaceutical sciences)

Tools

Microbiology equipment

Job description

Scorpion Therapeutics in New Jersey seeks a Lead QC Microbiology professional to manage GMP environmental monitoring, materials testing, and finished product microbiology.

You will establish and qualify a new QC Microbiology lab, oversee investigations and CAPAs, mentor a team, and ensure compliance with FDA/EU regulations.

On-site role with ~10% travel, supporting commissioning of facilities and regulatory inspections.