Microbiologist

Job Description

The microbiologist will work on the Analytical Development team, focusing on method feasibility, development, and validation of all compendial microbiology-related methods for new product transfers to the site. This role involves collaborating closely with the microbiology QC team and project team, as well as occasionally interfacing directly with external customers as a technical subject matter expert.

Responsibilities

• Perform method feasibility, development, and validation for microbiological methods related to new product transfers.
• Develop and validate compendial microbiological methods for sterile injection, non-sterile liquid suspension, and solid oral dose veterinary pharmaceutical products.
• Collaborate with the microbiology QC and project teams.
• Interface periodically with external customers as a technical subject matter expert.
• Author and execute method development and validation protocols and reports.
• Conduct sterility testing and validation of liquid injection products and sterile suspensions.
• Perform endotoxin testing and validation using kinetic chromogenic or turbidimetric methods.
• Carry out microbial limits testing and validation for non-sterile liquids, pastes, suspensions, and raw materials.
• Execute subvisible particulate testing using light obscuration and microscopy.
• Contribute to media growth promotion and microbial identification tasks.

Essential Skills

• Bachelor’s degree in a scientific field with 4+ years of experience.
• Experience in a cGMP FDA 21CFR210/211 pharmaceutical manufacturing quality control role.
• Proficiency in method development and validation protocol authoring.
• Experience in sterility USP <71> testing and method validation.
• Endotoxin USP <85> testing and method validation experience.
• Microbial Limits Testing USP <61> and <62> experience.
• Subvisible particulate testing per USP <788> experience.
• Knowledge of media growth promotion and microbial identification.

Additional Skills & Qualifications

• Method development/validation.
• Aseptic technique.
• Endotoxin.
• Bioburden.
• Sterility.
• Particulate Testing
• ELISA.
• Cell culture.

Work Environment

Monday to Friday from 8 AM to 5 PM.