The ideal candidate is a motivated and experienced Scientist focused on Quality Control Microbiology, responsible for compendial and rapid microbiology lab methods, serving as the technical lead for evaluation, validation, and implementation of new microbiology methods and EM program.
- Author, review and execute SOPs, protocols, reports relating to GMP microbiology processes, test methods and related equipment.
- Oversee and perform the day to day activities related to Environmental monitoring, product release testing, and contamination control.
- Implement, maintain, and oversee environmental monitoring program, personnel monitoring, trending and analysis.
- Identify key microbial technologies and oversee the project from beginning to end.
- Develop and refine strategies and methodologies for microbiological testing, cleaning validations.
- PhD in a related science field and 2+ years or Masters degree in a related science field and 6+ years or Bachelors degree in a related science and 8+ years of GxP experience in the biotech or pharma industry specific to microbial contamination and controls.
- Demonstrated knowledge leading major investigations related to microbial contamination.
- Strong knowledge and experience in several of the following areas of competency: aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
- Expert knowledge and understanding of Microbiology principles, theories, concepts and lab methodologies.