QC Analytical Lead

Overview

The QC Analytical Lead is responsible for establishing and managing all analytical operations for the QC function at WuXi STA’s new drug product manufacturing site in Middletown, DE. This role will oversee laboratory build-out during site startup, including equipment procurement and qualification, method transfers from global R&D and client facilities, and the implementation of GMP-compliant systems for testing drug products, raw materials, and components. The QC Analytical Lead will ensure timely and accurate execution of release and stability testing to support manufacturing and packaging operations, and will provide analytical support for process validation, cleaning validation, and packaging verification. This position serves as the subject matter expert (SME) for analytical techniques, ensuring regulatory compliance, data integrity, and inspection readiness at all times.

Responsibilities

Analytical Laboratory Leadership• 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.Method Transfer, Validation, and Testing Support• 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.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 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.Technical Leadership

• 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.People Management & Leadership• 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.

Qualifications

• 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.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.