QC Microbiology Lead

Overview

The QC Microbiology Lead will manage all microbiology laboratory activities at WuXi STA’s drug product manufacturing site in Middletown, DE. This role is responsible for establishing, maintaining, and continuously improving GMP-compliant microbiological testing programs for drug product manufacturing, including environmental monitoring (EM), water system monitoring, bioburden, endotoxin, and identification testing. The QC Microbiology Lead will play a key role in site startup by building the micro lab infrastructure, qualifying equipment, and establishing EM programs. In steady-state operations, this role will ensure timely execution of microbiology testing to support manufacturing, product release, cleaning validation, and regulatory readiness.

Qualifications

• PhD in Microbiology or related field preferred; Master’s or Bachelor’s degree with extensive relevant experience will also be considered.• Minimum 7 years of microbiology QC experience in GMP-regulated drug product manufacturing, with demonstrated leadership or supervisory responsibilities.• Proven expertise in microbiology method transfer, validation, and compendial testing for finished dosage forms.• Strong understanding of ICH, USP <61>, <62>, <85>, <1116>, EP, JP, FDA, and EMA regulatory requirements for drug product QC.• Demonstrated ability to manage teams in a fast-paced manufacturing environment with multiple client projects.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Responsibilities

Microbiology Laboratory Leadership• Lead the setup and daily operations of the QC Microbiology laboratory for drug product manufacturing, ensuring alignment with corporate quality standards.• Oversee procurement, installation, qualification, calibration, and maintenance of microbiology equipment including biosafety cabinets (BSCs), incubators, autoclaves, particle counters, endotoxin testing systems, and microbial identification instruments.• Develop, implement, and maintain SOPs, test methods, and microbiological procedures in compliance with ICH, USP <61>, <62>, <85>, <1116>, EP, and JP requirements.• Establish and manage workflows to ensure microbiological testing supports manufacturing and packaging schedules.Method Transfer, Validation, and Testing Support• Lead microbiological method transfers and validations from WuXi STA global R&D sites and client facilities for drug product testing.• Ensure robustness, reproducibility, and regulatory compliance of validated microbiology methods.• Oversee and review microbiology data for environmental monitoring (EM), water system monitoring, bioburden, endotoxin, and microbial identification testing.• Provide microbiological support for process validation, cleaning validation, and contamination control strategy implementation.• Provide timely review and approval of microbiological data to meet batch release and stability program timelines.

Regulatory Compliance• Ensure all analytical testing meets FDA, EMA, and ICH regulatory requirements for drug product QC.• Maintain compliance with data integrity principles (ALCOA ), ensuring accurate and complete documentation.• Prepare microbiology teams for client and regulatory inspections, acting as the primary microbiology SME during audits.• Monitor industry trends, regulatory updates, and compendial changes, ensuring methods and procedures remain compliant.Technical Leadership

• Act as SME for microbiological techniques including EM, endotoxin testing (USP <85>), microbial limits testing (USP <61>/<62>), microbial identification, and water system monitoring.• Lead troubleshooting of complex microbiological issues, overseeing root cause analysis and CAPA implementation.• Collaborate with QC Analytical and QC Operations to optimize sample management, workflows, and shared resources.• Identify and recommend new microbiological technologies or automation to improve efficiency, accuracy, and throughput.People Management & Leadership• Build, lead, and develop the microbiology laboratory team, defining roles, responsibilities, and performance expectations.• Provide coaching, technical training, and career development opportunities for team members.• Conduct regular performance evaluations, manage staffing levels, and ensure adequate coverage for operations.• Foster a culture of accountability, collaboration, and continuous improvement within the team.