QC Microbiology Scientist

Reporting to the QC Microbiology Lead, this role performs advanced microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site.

Responsibilities

• Perform and review advanced microbiological QC testing for drug products, raw materials, packaging components, and utilities in accordance with approved methods and SOPs.
• Lead and execute environmental monitoring, bioburden, endotoxin, microbial limits, microbial identification, and sterility testing.
• Provide scientific expertise in troubleshooting, investigations, and technical issue resolution.
• Author, review, and revise SOPs, test methods, and technical documents.
• Mentor and train QC Analysts and Associates on microbiological methods and best practices.
• Ensure all activities are conducted in strict compliance with cGMP, safety, and quality standards.
• Maintain accurate, complete, and inspection-ready microbiology laboratory documentation.
• Participate in method transfer, qualification, and validation of microbiological methods and equipment.
• Support client and regulatory audits by presenting data, explaining technical approaches, and preparing responses.
• Escalate deviations, out-of-specification (OOS) results, or atypical findings promptly to the QC Microbiology Manager.
• Perform other QC tasks assigned by the microbiology lead.

Requirements

• Bachelor’s degree in Microbiology, Biology, or related scientific discipline with 5+ years of QC microbiology experience in a GMP-regulated pharmaceutical or biotechnology environment; OR Master’s degree with 3+ years or PhD with 1+ years of relevant QC microbiology experience.
• Deep expertise in microbiological techniques and instrumentation, including environmental monitoring, sterility, endotoxin, and bioburden testing.
• Demonstrated ability to lead investigations, author technical reports, and drive resolution of complex issues.
• Strong knowledge of GMP regulations, USP, ICH guidelines, and data integrity principles.

Preferred Qualifications

• Experience with LIMS, Empower, or other electronic laboratory systems.
• Previous work in a CDMO or multi-client environment.
• Demonstrated ability to provide technical training and mentorship.
• Strong communication skills and ability to support audits and regulatory inspections.