We are looking for a microbiologist Supervisor who provides microbiology subject matter expertise to the company. The person will be responsible for performing and reviewing all types of microbial testing on raw materials, components, finished products, utility and environmental monitoring samples to ensure all testing comply with USP and cGMP guidelines.
- Perform required microbiological testing on raw materials, components, finished products, in process samples, environmental monitoring samples, utility samples, cleaning validation samples, etc.
- Perform environmental monitoring and utility sampling in manufacturing areas, including tracking & trending test results.
- Prepare and review all types of microbial test protocols and reports to ensure all testing comply with USP and cGMP guidelines
- Prepare and review EMPQ protocols and reports
- Interpret microbiological test results from external testing laboratories.
- Improve existing test methods. Develop new test methods.
- Write and review test procedures, SOPs, technical protocols/reports, microbiological section of ANDA submission and other documents.
- Prepare protocol and report for Aseptic Process Simulation and participate actively
- Assist with deviation investigations and corrective action/preventative action creation and execution
- Perform troubleshooting and investigations on method development, verification and validation
- Advanced degree (MS or Ph.D) in Microbiology with a minimum of 1-3 years’ experience or Bachelor degree in Microbiology with a minimum 3 to 5 years’ experience in a pharmaceutical industry. A strong background in fundamental microbiology is necessary.
- Familiar with USP sterility testing, USP bacterial endotoxin testing, USP microbial limits testing, Gram staining, microbial ID testing, utility and Environmental monitoring, etc.
- Familiar with microbial identifications
- Familiar with cGMP/GLP requirements and preparation of submission documents for Regulatory fillings
- In-depth knowledge of viable and non-viable environmental monitoring during pharmaceutical manufacturing and an understanding of aseptic techniques is a plus
- Be able to work efficiently and handle multiple tasks simultaneously
- Possess good communication skills (both oral and written).
- Hardworking and a good team player