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Microbiologist Lead

Employer
Fordoz Pharma Corp.
Location
Hightstown, New Jersey, US
Salary
Competitive
Closing date
Dec 3, 2021

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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Job Brief

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.

Job Responsibilities

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

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, 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

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: $60,000.00 - $120,000.00 per year

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

Schedule:
  • 8 hour shift

Work Location:
  • One location

Work Remotely:
  • No

Work Location: One location

by Jobble
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