Job Details
A rapidly growing biotech organization is growing out their microbiology team! This is not a bench position. This position is more centered towards contamination control and method validation. See the key responsibilities below:
Sterility Assurance and Contamination Control
- Ensure the site's compliance with sterile processing and contamination control standards, including environmental monitoring, clean-room management, and sterilization.
- Develop and maintain strategies to control microbial contamination and cross-contamination.
- Support the development of contamination control strategies and maintain risk assessments related to microbial contamination.
Environmental Monitoring and Utilities
- Oversee environmental monitoring programs, including utilities and trending reports for compliance and technical accuracy.
- Develop strategies for effective environmental monitoring and oversee site-wide testing for contamination.
Technical Writing and Communication
- Author and revise procedures and technical documents for sterility assurance.
- Communicate with senior management about contamination control issues.
- Participate in continuous improvement initiatives and promote best practices for contamination control.
Microbiological Expertise
- Ensure compliance with global standards and regulations for microbiology and sterility assurance.
- Troubleshoot contamination issues and support related investigations.
- Provide oversight for microbiological testing performed in-house and at contract laboratories.
- Microbial method validations.
Key Qualifications:
- Bachelor s degree in the Microbiology, Life Science, or related field.
- Minimum of 5 years of QC Microbiology experience in the pharma/biotech industry.
- Experience with rapid microbial test methods: sterility, endotoxin, and/or mycoplasma
- Experience in microbial contamination control.
- Experience with microbiological risk assessments.
- Experience with cell therapy products is a plus.