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Scientist, Microbiology – Sterility Assurance
GSKMicrobiology scientist leading sterility assurance for GSK’s sterile R&D manufacturing facility. Supporting contamination control, microbiological testing, investigations, validation, and product release.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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.
Highest-signal resume keywords
Microbiology SupportAseptic ProcessingEnvironmental MonitoringCGMP PrinciplesBioburden Testing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Microbial IdentificationEndotoxin TestingMethod DevelopmentValidationContamination ControlSOP DevelopmentSampling PlansRisk AssessmentTechnical InvestigationsData Review
Soft Skills
Clear CommunicationLeadership
Tools & Technologies
Laboratory Information Management Systems (LIMS)Electronic Documentation
Industry Keywords
PharmaceuticalBiotechSterile ManufacturingRegulatory Quality StandardsPharmacopeial Microbiology Standards
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Comprehensive benefits program for US employees
- Growth opportunities
- Employee wellbeing support
- Equal opportunity workplace
- Accommodation or other assistance available during the application process