Associate Director, QC Microbiology

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

Role

Lead and manage all QC Microbiology laboratory activities supporting GMP manufacturing, including environmental monitoring and microbiological testing of materials, intermediates, and finished products.

Responsibilities

• establish and qualify 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

Qualifications

• minimum 8 years' experience in an FDA-regulated biopharma or biotech environment, with at least 5 years in team management
• Expertise in pharmaceutical microbial testing, microbiology equipment, and regulations (USP/EP, cGMP/EU GMP)
• Bachelor’s in science (microbiology, biotech, pharmaceutical sciences)
• Strong leadership, analytical, project management, and communication skills

Work setup

On-site with approximately 10% travel; involved in commissioning and regulatory compliance activities.