WuXi AppTec · 5 hours ago
QC Microbiology Lead
Middletown, DE
Full-time
Onsite
Senior Level
7+ years expWuXi AppTec is a drug product manufacturing company seeking a QC Microbiology Lead to manage microbiology laboratory activities. This role involves establishing and improving GMP-compliant microbiological testing programs and ensuring timely execution of testing to support manufacturing and regulatory readiness.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
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 , , , , EP, and JP requirements
Establish and manage workflows to ensure microbiological testing supports manufacturing and packaging schedules
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
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
Act as SME for microbiological techniques including EM, endotoxin testing (USP ), microbial limits testing (USP /), 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
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
Qualification
Required
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, 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
Company
WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical.
10001+ employees
H1B Sponsorship
WuXi AppTec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
2021 (1)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.59BKey Investors
Eight Roads Ventures
2025-03-03Acquired
2018-05-08IPO
2016-03-06Debt Financing· $1.5B
Leadership Team
Ge Li
Founder, Chairman and CEO
Recent News
MarketScreener
2025-12-22
South China Morning Post
2025-12-19
Company data provided by crunchbase