Senior Leader, QC Microbiology — Sterile Injectables

RXinsider LTD.; Chandler (AZ); On-site; USD 140,000 - 190,000; Full time

Job summary

RXinsider LTD. seeks a Director/Associate Director of QC Microbiology to lead the sterile injectable microbiology program. You will oversee environmental monitoring, sterility assurance, investigations, and regulatory compliance while serving as the site SME for microbiology.

The role includes leading aseptic processing support, contamination control strategy, and inspection readiness to ensure product quality and patient safety. Strong leadership and regulatory experience are required.

Qualifications

• Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, or related field.
• 10+ years of microbiology experience in sterile pharmaceutical manufacturing.
• 5+ years of leadership experience in QC Microbiology.
• Strong expertise in environmental monitoring, aseptic processing, sterility assurance, and contamination control.
• Experience supporting FDA inspections and regulatory compliance activities.

Responsibilities

• Lead day-to-day QC Microbiology laboratory operations.
• Manage staffing, training, budgets, inventory, and equipment.
• Develop and mentor microbiology personnel.
• Oversee sterility, endotoxin, bioburden, and antimicrobial testing.
• Lead investigations, CAPA, and regulatory documentation.

Skills

QC Microbiology Leadership

Environmental Monitoring

Aseptic Processing

Regulatory Compliance

Investigations & CAPA

Team Leadership

Data Integrity

Education

Bachelor's in Microbiology or related field

Master's degree (preferred)

Tools

Isolators

Rapid Microbiological Methods

Sterile Injectable Manufacturing

Job description

RXinsider LTD. seeks a Director/Associate Director of QC Microbiology to lead the sterile injectable microbiology program. You will oversee environmental monitoring, sterility assurance, investigations, and regulatory compliance while serving as the site SME for microbiology.

The role includes leading aseptic processing support, contamination control strategy, and inspection readiness to ensure product quality and patient safety. Strong leadership and regulatory experience are required.