Microbiologist - Compendial Method Development

Microbiologist
- Pharmaceutical Method Development

Job Description 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 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.

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. + Perform media growth promotion testing and microbial identification to confirm suitability of culture media and accurately identify microorganisms as required. + 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.

Essential Skills + 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.

+ 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.

+ Practical experience performing bioburden, sterility, and related microbiological quality control tests. + Strong understanding of cGMP principles and quality control practices in a regulated pharmaceutical environment. Job Type & Location This is a Contract to Hire position based out of Lenexa, KS. Pay and Benefits The pay range for this position is $35.00 - $44.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are…