QC Microbiology Technical Lead

Overview

We are seeking an experienced QC Microbiology Technical Lead to provide technical oversight of microbiology laboratory operations. This role will serve as a functional leader on the bench, supporting testing, data review and approval, investigations, documentation, and continuous improvement initiatives.

Key Responsibilities

• Provide technical oversight and expertise across QC Microbiology activities, including Endotoxin, Bioburden, Microbial Identification, Environmental Monitoring, and other microbiological assays .
• Perform and support laboratory testing while ensuring activities are conducted in compliance with cGMP, GDP, FDA, USP, EP, ICH, EU Annex 1, DEA, OSHA , and other applicable regulations and standards.
• Perform data review and approval to support daily laboratory operations and ensure accurate, compliant results.
• Author, review, and approve SOPs, protocols, specifications, validation reports, impact assessments, and other technical documentation .
• Lead and support microbiological OOS and deviation investigations , including root cause analysis, risk assessment, and development of effective CAPAs.
• Promote risk-based and data-driven approaches to improve investigation quality, compliance, and efficiency.
• Provide training, coaching, and mentorship to junior laboratory personnel.
• Support strategic laboratory initiatives designed to improve efficiency, technology, and overall laboratory capabilities.
• Use microbiological data to support risk-based decision-making related to aseptic processing, facility controls, environmental monitoring, and manufacturing practices.
• Lead and support projects involving new laboratory capabilities, technology implementation, method development, validation, and lifecycle programs .
• Collaborate with cross-functional teams to ensure laboratory activities align with business priorities, regulatory expectations, and manufacturing needs.

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline .
• 7+ years of experience in pharmaceutical or biotechnology quality laboratories.
• Strong knowledge of cGMP and global regulatory requirements , including USP, EP, ICH, and EU Annex 1.
• Experience developing, validating, verifying, and transferring microbiological and environmental monitoring methods .
• Strong technical writing, communication, organizational, and problem-solving skills.
• Ability to create and review clear, accurate, and inspection-ready documentation .
• Demonstrated ability to work independently while providing technical leadership and guidance to laboratory teams.

Preferred Qualifications

• Experience supporting both development and commercial manufacturing environments.
• Previous experience working in a CDMO, multi-product, or biologics manufacturing facility .
• Experience using MODA or similar environmental monitoring/data management systems .
• Experience leading laboratory investigations, process improvements, or implementation of new technologies.