Overview:
Reporting to the QC Microbiology Lead, the QC Microbiology Scientist will perform advanced microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes execution and troubleshooting of microbiological testing, environmental monitoring, stability sample handling, equipment operation, method transfers, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Microbiology Scientist will support both startup and steady-state operations, ensuring timely and accurate completion of QC tasks for product release, stability studies, validation, and regulatory audits.
Responsibilities:
Microbiological Testing and Support
- 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.
- Other QC tasks assigned by microbiology lead.
Regulatory Compliance and Documentation
- 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.
Qualifications:
- 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 <61>, <62>, <85>, <1116>, 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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.