Principal Scientist - Sterility Assurance
About the role 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. Key responsibilities 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
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
About you 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