Scientist, Microbiology – Sterility Assurance

• Lead microbiology and sterility assurance activities for a sterile R&D manufacturing facility
• Provide hands-on microbiology support for aseptic processing, environmental monitoring, and gowning qualifications
• Lead investigations of unexpected microbiological results and drive corrective actions with root-cause and risk assessment
• Perform and review bioburden, sterility, endotoxin, microbial identification, and water testing
• Develop, revise, and approve microbiological methods, SOPs, and sampling plans supporting product release and stability programs
• Partner with manufacturing, quality, and development teams on contamination control and sterility assurance strategies
• Support validation activities, method transfers, and evaluation of rapid microbiological technologies

• Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related scientific discipline
• Minimum 3 years’ hands‑on experience in a pharmaceutical, biotech, or sterile manufacturing microbiology laboratory
• Experience with environmental monitoring, aseptic techniques, gowning, and contamination control
• Knowledge of cGMP principles and experience working to regulatory quality standards
• Experience performing bioburden, sterility, endotoxin testing, and microbial identifications
• Advanced degree in Microbiology or a related field preferred
• Experience with microbiological assay method development, validation, or transfers preferred
• Familiarity with pharmacopeial microbiology standards and compendial methods preferred
• Experience using laboratory information management systems (LIMS) and electronic documentation preferred
• Prior experience reviewing microbiology data for regulatory submissions or CMC support preferred
• Ability to lead technical investigations and communicate findings clearly to stakeholders preferred

Demonstrates expertise in microbiology and sterility assurance within sterile R&D manufacturing, with a strong focus on environmental monitoring, aseptic processing, and regulatory compliance. Proficient in developing microbiological methods and leading investigations to ensure product quality and safety.

• Microbiology Support
• Aseptic Processing
• Environmental Monitoring
• CGMP Principles
• Bioburden Testing

• Microbial Identification
• Endotoxin Testing
• Method Development
• Validation
• Contamination Control
• SOP Development
• Sampling Plans
• Risk Assessment
• Technical Investigations
• Data Review

• Clear Communication
• Leadership

• Pharmaceutical
• Biotech
• Sterile Manufacturing
• Regulatory Quality Standards
• Pharmacopeial Microbiology Standards

• Laboratory Information Management Systems (LIMS)
• Electronic Documentation