Microbiologist

Job Brief

We are looking for a microbiologist 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, environmental monitoring samples to ensure all testing comply with USP and cGMP guidelines.

Job Responsibilities

· Perform required microbiological testing on raw materials, components, finished products, in process samples, environmental monitoring samples, WFI, Cleaning validation samples, etc.

- Perform environmental monitoring 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

· 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.

- Assist with deviation investigations and corrective action/preventative action creation and execution

· Perform troubleshooting and investigations on method development, verification and validation

Requirements

· 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, 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 task simultaneously

· Possess good communication skills (both oral and written).

· Hardworking and a good team player

ForDoz 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: $55,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person