Director, Quality Control Microbiology

Resilience

Biotechnology

East Norriton, PA - USA

Manager / Team Leader

Experteer Overview

In this role you lead the site Quality Control Microbiology function to develop and run the environmental monitoring and microbiology testing programs at the East Norriton manufacturing site. You will shape SOPs, methods, and equipment qualification to ensure compliant, high-quality cell therapy production. You’ll partner across functions to address EM data, excursions, and regulatory expectations, driving continuous improvement. This is an opportunity to impact biomanufacturing at scale through rigorous quality and collaboration.

Compensation / Benefits

annual cash bonus
401(k) with company match
comprehensive healthcare (medical, dental, vision)
family building benefits
life and disability insurance
flexible time off

Responsibilities

Develop and manage the Environmental Monitoring program lifecycle, including performance qualification, routine monitoring, data trending, and excursion investigations
Contribute to selecting and implementing electronic tools for EM program management and laboratory notebooks
Create and maintain site-specific microbial contamination control SOPs
Develop and manage microbiology methods including qualification, approval, and execution
Plan and deliver on-the-job training for QC Microbiology staff and ensure GMP/compliance proficiency
Oversee laboratory equipment qualification and ensure compliance with Part 11 and data integrity
Schedule and review microbiological testing of materials, intermediates, and drug products; ensure timely deliverables
Support method validation/verification activities for site microbiology testing
Lead the site QC team, manage performance, and coordinate with stakeholders
Develop departmental goals and budget aligned with site and corporate objectives
Support additional quality initiatives as needed

Key requirements

Experience with EM programs, utilities monitoring, and drug product microbiological testing
Experience with environmental monitoring performance qualification
Experience with aseptic processing operations
Strong cross-functional collaboration and communication in fast-paced environments
Excellent written and oral communication with technical writing skills
Comprehensive knowledge of global cGMP requirements for biologics, cell, and gene therapy products

strong leadership and people management clear communication and technical writing cross-functional collaboration Environmental Monitoring (EM) program management Microbiology testing and method development/validation Laboratory equipment qualification and Part 11/data integrity compliance

Description

In this role you lead the site Quality Control Microbiology function to develop and run the environmental monitoring and microbiology testin…

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