Microbiologist, Pharmaceutical Method Development
Overview
You will own compendial microbiology method development and validation for a growing pharmaceutical facility in Shawnee, KS. You will support new product transfers across sterile injections, non-sterile suspensions, and solid oral veterinary products. You'll collaborate with the QC team and external customers as a technical subject matter expert under QC leadership. This role offers direct impact on method quality and regulatory compliance in a small team environment.
What You'll Do10
- 1Develop and validate compendial microbiology methods for sterile injections and non-sterile suspensions using USP standards.
- 2Author and execute method validation protocols, including writing validation reports aligned with SOPs.
- 3Conduct sterility testing per USP using isolator-based methods for liquid injections and sterile suspensions.
- 4Perform endotoxin testing using kinetic chromogenic and turbidimetric methods per USP.
- 5Execute microbial limits testing for non-sterile liquids, raw materials, and bulk injection solutions per USP and USP.
- 6Run subvisible particulate testing using light obscuration and microscopy per USP.
- 7Complete media growth promotion testing and microbial identification to ensure media suitability.
- 8Apply aseptic technique and cell culture practices for contamination control in the lab.
- 9Perform bioburden and sterility tests as part of routine QC and validation programs.
- 10Collaborate with cross-functional project teams to meet timelines and resolve technical issues.
Requirements10
- 1Bachelor’s degree in microbiology, biology, or a related field.
- 24+ years of pharmaceutical QC experience under cGMP and FDA 21 CFR 210/211.
- 3Hands-on method validation experience, including authoring protocols and writing reports.
- 4Proven sterility testing per USP with isolator experience preferred.
- 5Endotoxin testing per USP using kinetic chromogenic or turbidimetric methods.
- 6Microbial limits testing per USP and USP for non-sterile products.
- 7Subvisible particulate testing per USP using light obscuration.
- 8Proficient in media growth promotion and microbial identification techniques.
- 9Strong aseptic technique and cell culture competency.
- 10Practical bioburden and sterility testing experience in a regulated environment.
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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