QC Principal Scientist - Sterility Assurance

WuXi XDC; Singapore; Vor Ort; SGD 78.000 - 145.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Sterility assurance

Aseptic processing

Regulatory inspections

CAPA investigations

Ausbildung

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

Tools

GMP knowledge

Jobbeschreibung

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.