Full Time QC Principal Scientist - Sterility Assurance Jobs, in WuXi XDC - Maukerja

As part of this role, successful candidate will complete a 6-month assignment at Wuxi China site, gaining valuable experience prior to returning to Singapore to support XDC Singapore operations.

Responsibilities:

• Lead and oversee the site sterility assurance program to ensure compliance with current GMP requirements and regulatory expectations for biologics and sterile drug product manufacturing.
• Provide microbiological and contamination control expertise to manufacturing, quality, engineering, and validation teams throughout the product lifecycle.
• Own and maintain the Contamination Control Strategy (CCS), ensuring effective implementation of aseptic processing and microbial risk mitigation measures.
• Support aseptic manufacturing operations, including media fills (APS) and aseptic process qualification.
• Review and approve environmental monitoring, cleanroom qualification, utilities monitoring, personnel monitoring, and microbiological trending programs.
• Conduct contamination investigations, sterility test investigations, environmental excursions, and root cause analyses, ensuring timely and effective CAPA implementation.
• Lead microbiological risk assessments for manufacturing processes, facility changes, process transfers, and new product introductions.
• Ensure compliance with GMP requirements related to cleanroom design, HVAC systems, water systems, gas systems, and sterilization processes.
• Partner with Manufacturing Science & Technology (MSAT), Validation, Engineering, and Quality teams to support process improvements and technology transfers.
• Support regulatory inspections, customer audits, and internal audits by serving as the subject matter expert for sterility assurance and contamination control.
• Develop and deliver training programs on aseptic techniques, cleanroom behaviors, contamination control, and GMP microbiology to enhance operational excellence and compliance culture.

Preferred Qualifications

• Bachelor's, Master's, or PhD in Microbiology, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.
• Strong experience in biologics, sterile injectables, vaccines, cell and gene therapy, or aseptic pharmaceutical manufacturing.
• In-depth knowledge of EU GMP Annex 1, FDA aseptic processing guidance, microbial contamination control, and sterile manufacturing regulations.
• Demonstrated experience supporting regulatory inspections and managing contamination control programs in a GMP environment.