A rapidly expanding biotech organization is growing out their microbiology team! This position will be driving the development and oversight of the organization's microbial contamination control programs, and support related new product transfers as well as microbiological risk assessments, and trend reports. As the Associate Director of the team's Microbiology department, you'd serve as the subject matter expert in microbiology test methods.
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 8 years of QC Microbiology experience in the pharma/biotech industry.
- Experience with rapid microbial test methods and performing method validations.
- Experience in microbial contamination control, and strong knowledge of clean room qualification and management.
- Experience with microbiological risk assessments.
- Experience with cell therapy products is a plus.
