Category: Manufacturing & Production

Employment Type: Contract

Reference: BH-372714

QC Microbiologist needed for a contract opportunity with Yoh Scientific's client located in Rockville, MD.

This position is for a pharmaceutical company and is seeking an Expert Scientist in Quality Control Microbiology with experience or specialty in endotoxin detection methods. The ideal candidate would have 3 years or more experience in working in research and/or analytical development and/or quality control functions.

Shift: Monday through Friday, standard day shift. 100% onsite.

Key Responsibilities

• Design and execute method development and GMP validation for recombinant factor C endotoxin testing.
• Contribute to method development and method qualification.
• Perform laboratory operations to support and implementation of compliant, state of art methodology and instrumentation.
• Provide scientific understanding and analytical support for development of new test method, validation, and specifications.
• Support for scientific report writing and document revision.
• Provide analytical troubleshooting support for investigations which require non routine/specialized service.
• Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment.
• Provide validation and testing data for these new methods and technologies for internal advocacy and external regulatory submission.
• Facilitate method transfer, validation, and implementation of new microbiology technologies at secondary commercial sites.
• Work to GMP standards as appropriate.
• Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

• BSc in Biological Sciences or related area; Microbiology, Biochemistry or a related subject.
• 3 years or more experience in working in research and/or analytical development and/or quality control functions.
• An understanding of the theoretical and practical aspects of Pharmaceutical Microbiology (knowledge of rapid/alternative methodologies an advantage).
• Demonstrated hands-on and/or practical experience in endotoxin detection methods of pharmaceutical products and/or water.
• Capacity to think innovatively and flexibly for new microbiology methodology implementation, comfortable with complexity.
• Experience in microbiology method and equipment development and/or validation.
• Knowledge of biological and pharmaceutical product manufacturing and microbial control.
• Experience with FDA regulations.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs