QC Physiochemistry Lead Scientist

WuXi Biologics; Cranbury Township (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

WuXi Biologics seeks a Senior Scientist I, QC Physiochemistry Lead, to lead physiochemical testing for clinical and commercial biologics. You will oversee method execution, data integrity, investigations, deviations, and CAPAs while developing a high-performing QC team.

This role partners with Manufacturing, QA, Regulatory, and Client Program teams. You will manage QC staff, ensure training and qualification, and drive continuous improvement in QC processes, supporting regulatory inspections and

Qualifications

• Minimum 3-5 years of hands on expereince with HPLC, CE, ICIEF.
• Minimum 1-2 years of previous management experience with direct reports.
• 3+ years of QC experience in the pharmaceutical or biopharmaceutical industry
• Proven experience supporting clinical and/or commercial manufacturing environments
• Strong working knowledge of QC operations for biologics, including method execution, data review, and laboratory compliance.
• In‑depth understanding of global regulatory requirements and guidance, including cGMP, FDA, EMA, ICH, and major pharmacopeias.

Responsibilities

• QC Operations & Compliance: Provide leadership and oversight for daily QC Physiochemistry operations.
• Ensure all testing activities are conducted in compliance with cGMP, GLP, CFR, and internal SOPs.
• Lead and oversee data review, investigations, deviations, and CAPAs.
• Serve as site SME for physiochemical testing and related investigations.
• Review and approve laboratory documentation, including notebooks, worksheets, protocols, and final reports.

Skills

Leadership

Communication skills

Time management

Cross-functional collaboration

Problem solving

Tools

HPLC/UPLC

Capillary Electrophoresis (CE‑SDS, icIEF)

Identity methods

Protein Concentration methods

LIMS

Empower

Job description

WuXi Biologics seeks a Senior Scientist I, QC Physiochemistry Lead, to lead physiochemical testing for clinical and commercial biologics. You will oversee method execution, data integrity, investigations, deviations, and CAPAs while developing a high-performing QC team.

This role partners with Manufacturing, QA, Regulatory, and Client Program teams. You will manage QC staff, ensure training and qualification, and drive continuous improvement in QC processes, supporting regulatory inspections and