R&D Microbiologist

About the role

This role focuses on supporting a growing animal health pharmaceutical facility by performing microbiology quality control activities in a QC laboratory.

Responsibilities

• 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.
• 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.

Requirements

• 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 competency in aseptic technique and cell culture practices.
• Prior experience serving as a technical subject matter expert and interfacing with external customers or partners is beneficial.
• Familiarity with compendial microbiology methods and their application to sterile and non-sterile dosage forms.
• Strong understanding of cGMP principles and quality control practices in a regulated pharmaceutical environment.
• Strong written and verbal communication skills for documenting methods, authoring reports, and collaborating with cross-functional teams.
• Ability to work effectively in a small, collaborative microbiology team within a larger manufacturing and laboratory setting.
• Detail-oriented mindset with strong problem-solving skills and the ability to troubleshoot microbiological methods and assays.

Qualifications

• 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 competency in aseptic technique and cell culture practices.
• Prior experience serving as a technical subject matter expert and interfacing with external customers or partners is beneficial.
• Familiarity with compendial microbiology methods and their application to sterile and non-sterile dosage forms.
• Strong understanding of cGMP principles and quality control practices in a regulated pharmaceutical environment.
• Strong written and verbal communication skills for documenting methods, authoring reports, and collaborating with cross-functional teams.
• Ability to work effectively in a small, collaborative microbiology team within a larger manufacturing and laboratory setting.
• Detail-oriented mindset with strong problem-solving skills and the ability to troubleshoot microbiological methods and assays.

Skills

• Compendial microbiology methods.
• Method development and validation.
• Sterility testing.
• Endotoxin testing.
• Microbial Limits Testing.
• Subvisible particulate testing.
• Aseptic technique and cell culture practices.
• cGMP principles and quality control practices.
• Communication skills.

Benefits

Not specified.

Pay

$35.00 - $44.00/hr.

Schedule

Standard work hours are Monday through Friday, 8:00 a.m. to 5:00 p.m.

Location

Based out of Shawnee, KS.