Lead Sterility Assurance Scientist – Biologics & Aseptic

WuXi XDC; Singapore; On-site; SGD 78,000 - 145,000; Full time

Job summary

WuXi XDC is seeking a Sterility Assurance lead to oversee the site program for biologics and sterile drug products. The role includes ensuring GMP compliance, reviewing environmental monitoring, and leading investigations to prevent contamination.

The successful candidate will complete a 6-month assignment at Wuxi China site, gaining experience before returning to Singapore to support XDC Singapore operations.

Qualifications

• Bachelor's/Master's/PhD in Microbiology, Biological Sciences, Biotechnology, Pharmaceutical Sciences or related field.
• Strong experience in biologics, sterile injectables, vaccines, or aseptic manufacturing.

Responsibilities

• Lead and oversee the site sterility assurance program to ensure GMP compliance for biologics and sterile drug products.
• Provide microbiological and contamination control expertise to manufacturing, quality, engineering, and validation teams.
• Own and maintain the Contamination Control Strategy (CCS) and ensure aseptic processing and microbial risk mitigation.
• Support aseptic manufacturing operations, including media fills and aseptic process qualification.
• Review environmental monitoring, cleanroom qualification, utilities, and personnel monitoring programs.

Skills

Sterility assurance

Aseptic processing

Regulatory inspections

CAPA investigations

Education

Bachelor's/Master's/PhD in Microbiology/Biological Sciences/Biotechnology/Pharmaceutical Sciences

Tools

GMP knowledge

Job description

WuXi XDC is seeking a Sterility Assurance lead to oversee the site program for biologics and sterile drug products. The role includes ensuring GMP compliance, reviewing environmental monitoring, and leading investigations to prevent contamination.

The successful candidate will complete a 6-month assignment at Wuxi China site, gaining experience before returning to Singapore to support XDC Singapore operations.