WuXi AppTec · 5 hours ago
QC Analytical Lead
Middletown, DE
Full-time
Onsite
Senior Level
7+ years expWuXi AppTec is a leading global pharmaceutical and biotechnology company, and they are seeking a QC Analytical Lead to manage analytical operations at their new drug product manufacturing site. This role involves overseeing laboratory setup, ensuring compliance with regulatory standards, and providing analytical support for various validation processes.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Lead the setup and day-to-day operations of the QC Analytical laboratory for drug product manufacturing, ensuring alignment with corporate quality standards
Oversee procurement, installation, qualification, calibration, and maintenance of analytical equipment including HPLC, GC, TOC, dissolution testers, UV-Vis, KF titrators, and related instruments
Develop, implement, and maintain SOPs, test methods, and analytical procedures in compliance with ICH, USP, EP, and JP requirements
Establish and manage workflows to ensure analytical testing supports manufacturing and packaging schedules
Lead method transfers and validations from WuXi STA global R&D sites and client facilities, ensuring robustness, reproducibility, and regulatory compliance
Oversee execution and review of analytical testing for finished dosage forms, stability studies, and raw materials
Provide technical support for process validation, cleaning validation, and packaging verification activities
Ensure timely review and approval of analytical 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 analytical teams for client and regulatory inspections, acting as the primary analytical SME during audits
Monitor industry trends, regulatory updates, and compendial changes, ensuring methods and procedures remain compliant
Serve as SME for analytical techniques such as HPLC, GC, TOC, dissolution testing, UV-Vis, and other compendial methods relevant to drug product QC
Troubleshoot complex analytical issues, driving investigations, deviations, and CAPA implementation
Collaborate closely with QC Microbiology and QC Operations to coordinate workflows, sample management, and shared resources
Recommend and implement new technologies to improve testing efficiency, accuracy, and throughput
Build, lead, and develop the analytical 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 Chemistry or related field preferred; Master's or Bachelor's degree with extensive relevant experience will also be considered
Minimum 7 years of analytical QC experience in GMP-regulated drug product manufacturing, with demonstrated leadership or supervisory responsibilities
Proven expertise in analytical 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