WuXi AppTec · 14 hours ago
QC Analytical Scientist
Middletown, DE
Full-time
Onsite
Mid, Senior Level
3+ years expWuXi AppTec is a leading global pharmaceutical and biotechnology company, and they are seeking a QC Analytical Scientist to serve as a technical expert in analytical chemistry testing and laboratory operations. This role involves performing QC analytical testing, ensuring compliance with GMP standards, and supporting regulatory audits.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Perform and review QC analytical testing for drug products, raw materials, packaging components, and stability samples in accordance with approved methods and SOPs
Execute advanced analytical techniques including HPLC, UPLC, GC, dissolution, UV-Vis, TOC, Karl Fischer, and other relevant compendial and non-compendial methods
Troubleshoot analytical instrumentation and methods, supporting investigations and continuous improvement
Author, review, and revise test methods, SOPs, and technical documents
Mentor and train QC Analysts and Associates in analytical techniques and best practices
Other QC tasks assigned by analytical lead
Ensure all activities are conducted in strict compliance with cGMP, safety, and quality standards
Maintain accurate, complete, and inspection-ready laboratory documentation
Participate in method transfer, qualification, and validation of analytical methods and equipment
Support client and regulatory audits by presenting data, explaining technical approaches, and preparing responses
Escalate deviations, out-of-specification (OOS) results, or atypical findings promptly to the QC Analytical Manager
Qualification
Required
Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline with 5+ years of QC analytical laboratory experience in a GMP-regulated pharmaceutical or biotechnology environment; OR
Master's degree with 3+ years or PhD with 1+ years of relevant QC analytical laboratory experience
Deep expertise in chromatographic and spectroscopic methods (HPLC/UPLC, GC, UV-Vis, TOC, KF, etc.) and data interpretation
Demonstrated ability to lead laboratory investigations, troubleshoot instrumentation, and author technical reports
Strong knowledge of GMP regulations, ICH guidelines, and data integrity principles (ALCOA+)
Preferred
Experience in method transfer, qualification, and validation of analytical methods
Familiarity with LIMS, Empower, or other electronic laboratory management systems
Prior experience in a CDMO or multi-client environment
Strong communication and collaboration skills to support cross-functional teams, audits, and regulatory inspections
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
2026-01-03
MarketScreener
2025-12-22
Company data provided by crunchbase