R&D Microbiologist - Pharmaceuticals

Job Description

Job Description

This role focuses on supporting a growing pharmaceutical facility by performing microbiology quality control activities in a QC laboratory. The microbiologist develops, evaluates, and validates compendial microbiology methods to support new product transfers to the site, including sterile injections, non-sterile liquid suspensions, and solid oral dose veterinary pharmaceutical products. The position collaborates closely with the microbiology QC team, project teams, and external customers as a technical subject matter expert, while working under the guidance of analytical development or quality control leadership.

• Perform method feasibility, development, and validation for compendial microbiology methods supporting new product transfers to the site.
• Develop and validate microbiological methods for multiple product types, including sterile injection products, non-sterile liquid suspensions, and solid oral dose veterinary pharmaceutical drug products, as well as associated active pharmaceutical ingredients (APIs) and raw materials.
• Author, execute, and complete method development and validation protocols, including writing and reviewing validation reports in alignment with established templates and standard operating procedures (SOPs).
• Conduct sterility testing in accordance with USP , including method validation for liquid injection products and sterile suspensions, with preferred use of isolator-based testing where applicable.
• Perform endotoxin testing in accordance with USP , including method validation for liquid injection products, raw materials, and sterile suspensions using kinetic chromogenic or turbidimetric methods and associated instrumentation.
• Execute Microbial Limits Testing in accordance with USP and , including method validation for non-sterile liquids, pastes, suspensions, raw materials (solids and liquids), and bulk injection solutions.
• Conduct subvisible particulate testing per USP using light obscuration and microscopic methods to ensure compliance with particulate limits.
• Perform media growth promotion testing and microbial identification to confirm suitability of culture media and accurately identify microorganisms as required.
• Apply aseptic technique and cell culture practices to support microbiological assays and ensure contamination control in the laboratory.
• Carry out bioburden and sterility-related testing activities as part of routine quality control and method validation programs.
• Follow cGMP requirements and FDA 21 CFR 210/211 regulations in all laboratory operations, documentation, and quality control activities.
• Collaborate closely with the microbiology QC team and cross-functional project teams to support timelines, resolve technical issues, and ensure successful method transfer and implementation.
• Interface periodically with external customers as a technical subject matter expert to discuss methods, validation strategies, and testing results.
• Work under the direction of analytical development or quality control management while receiving training from microbiologists on SOPs, equipment operation, and documentation standards.
• Maintain accurate, complete, and compliant laboratory records, ensuring that all work aligns with established procedures and regulatory expectations.

• Bachelor’s degree in microbiology, biology, or a related scientific field.
• 4+ years of experience in a pharmaceutical manufacturing quality control role under cGMP, specifically aligned with FDA 21 CFR 210/211 requirements.
• Hands-on experience in method development and validation, including authoring validation protocols, executing studies, and writing validation reports.
• Demonstrated experience performing sterility testing in accordance with USP , including method validation for liquid injection products and sterile suspensions, with preferred experience using isolators.
• Experience performing endotoxin testing in accordance with USP , including method validation for liquid injection products, raw materials, and sterile suspensions using kinetic chromogenic or turbidimetric methods and related instrumentation.
• Experience with Microbial Limits Testing in accordance with USP and , including method validation for non-sterile liquids, pastes, suspensions, raw materials (solids and liquids), and bulk injection solutions.
• Experience conducting subvisible particulate testing per USP by light obscuration and microscopic methods.
• Proficiency in media growth promotion testing and microbial identification techniques.
• Demonstrated comp