We are looking for a microbiologist Lead 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 playerForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics.
Job Type: Full-time
Pay: $60,000.00 - $120,000.00 per year
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance
Work Location: One location