Microbiologist

Actalent; Kansas; On-site; USD 70,000 - 100,000; Full time

Job summary

Actalent in the United States is seeking a Microbiologist - Pharmaceutical Method Development to support a growing pharmaceutical facility by performing microbiology QC activities in a dedicated laboratory. You will develop, evaluate, and validate compendial microbiology methods to support new product transfers, including sterile injections, non-sterile liquids, and veterinary solid oral doses.

Under leadership, you will collaborate with the microbiology QC team and project partners, author

Qualifications

• Bachelor's degree in microbiology, biology, or related scientific field required.
• 4+ years in pharmaceutical QC under cGMP (FDA 21 CFR 210/211).
• Hands-on method development and validation experience.
• Experience with sterility testing per USP <71> and endotoxin testing per USP <85>.
• Experience with Microbial Limits Testing per USP <61>/<62>.
• Experience with subvisible particulate testing per USP <788>.

Responsibilities

• Perform method feasibility, development, and validation for compendial microbiology methods for product transfers.
• Develop/validate methods for sterile injections, non-sterile liquids, and veterinary APIs/ingredients.
• Author and review validation protocols and reports per SOPs.
• Conduct sterility testing per USP <71>, preferring isolator-based testing.
• Perform endotoxin testing per USP <85> with kinetic chromogenic or turbidimetric methods.
• Execute Microbial Limits Testing per USP <61>/<62> for various materials.
• Conduct subvisible particulate testing per USP <788> using light obscuration/microscopy.
• Apply aseptic technique and cell culture practices; maintain compliant lab records.
• Support cGMP and FDA 21 CFR 210/211 compliant operations and cross-functional collaboration.

Skills

Method development

Validation studies

Sterility testing

Endotoxin testing

Microbial Limits Testing

Subvisible particulate testing

Media growth promotion

Microbial identification

Aseptic technique

cGMP compliance

Education

Bachelor’s degree in microbiology, biology, or a related scientific field

Tools

Isolators

Job description

Job Description

Microbiologist - Pharmaceutical Method Development

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.

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 <71>, 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 <85>, 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 <61> and <62>, including method validation for non-sterile liquids, pastes, suspensions, raw materials (solids and liquids), and bulk injection solutions.
• Conduct subvisible particulate testing per USP <788> 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.

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 <71>, including method validation for liquid injection products and sterile suspensions, with preferred experience using isolators.
• Experience performing endotoxin testing in accordance with USP <85>, 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 <61> and <62>, 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 <788> by light obscuration and microscopic methods.
• Proficiency in media growth promotion testing and microbial identification techniques.
• Demonstrat