Pharmaceutical Microbiology Method Development Specialist

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

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