Job Title: Microbiologist

Job Description

The microbiologist will work in the microbiology QC laboratory, focusing on method feasibility, development, and validation of all compendial microbiology-related methods for new product transfers to the site. This position involves close collaboration with the microbiology QC team and project team, as well as direct interfacing with external customers as a technical subject matter expert.

Responsibilities

• Perform method development and validation for compendial microbiological methods for sterile injection, non-sterile liquid suspension, and solid oral dose veterinary pharmaceutical drug products.
• Collaborate with the microbiology QC team and project team.
• Interface with external customers as a technical subject matter expert.
• Author and execute method development and validation protocols, including report authoring.
• Conduct sterility USP testing and method validation for liquid injection products and sterile suspensions.
• Perform endotoxin USP testing and method validation using kinetic chromogenic or turbidimetric methods.
• Conduct microbial limits testing USP and for non-sterile liquids, pastes, suspensions, and raw materials.
• Perform subvisible particulate testing per USP using light obscuration and microscopy.
• Participate in media growth promotion and microbial identification, including cell culture.
• Utilize aseptic techniques.

Essential Skills

• Bachelor’s degree in a scientific field with 4+ years of experience.
• Prior work in a cGMP FDA 21CFR210/211 pharmaceutical manufacturing quality control role.
• Experience in method development and validation protocol authoring, execution, and report authoring.
• Sterility USP testing and method validation experience, preferably in an isolator.
• Endotoxin USP testing and method validation experience.
• Microbial Limits Testing USP and testing and method validation experience.
• Subvisible particulate testing per USP .
• Experience in media growth promotion and microbial identification.

Additional Skills & Qualifications

• Bachelor's degree in microbiology or biology.
• Experience with pharmaceutical method development and validation.
• Familiarity with sterility testing, microbiology, and ELISA.
• Proficiency in cell culture and aseptic techniques.

Work Environment

The role is based in a large manufacturing and lab facility with a gym on site. You will work with a small group of microbiologists from Monday to Friday, 8 AM to 5 PM. The facility is part of a growing Animal Health pharma sector, offering a dynamic and collaborative work environment.