R&D Microbiologist, Pharmaceutical Method Development
Overview
You will own method development and validation for compendial microbiology at a growing pharmaceutical facility in Shawnee, KS, supporting new product transfers for sterile injections, non-sterile suspensions, and veterinary solid doses. You will work with the QC microbiology team and project teams, acting as a technical subject matter expert under guidance from analytical development. The role covers the full spectrum: sterility, endotoxin, microbial limits, and subvisible particulates, all under cGMP and FDA 21 CFR 210/211. Your methods will directly enable product launches, and you will interface with external customers and lead validation protocols from start to finish.
What You'll Do10
- 1Develop and validate compendial microbiology methods for sterile injections, non-sterile suspensions, and solid oral veterinary products, including APIs and raw materials.
- 2Author and execute method development and validation protocols, writing validation reports per SOPs and templates.
- 3Perform sterility testing per USP , including validation for liquid injections and sterile suspensions, preferring isolator -based testing.
- 4Conduct endotoxin testing per USP using kinetic chromogenic or turbidimetric methods for injections, raw materials, and suspensions.
- 5Execute Microbial Limits Testing per USP for non-sterile liquids, pastes, suspensions, and bulk injection solutions.
- 6Run subvisible particulate testing per USP with light obscuration and microscopy.
- 7Apply aseptic technique and cell culture for media growth promotion and microbial identification.
- 8Support bioburden and sterility testing across routine QC and validation programs.
- 9Maintain compliant records under cGMP and FDA 21 CFR 210/211, collaborating with cross-functional teams and external customers.
- 10Troubleshoot microbiological assays and contribute to method transfer and implementation.
Requirements10
- 1Bachelor's degree in microbiology, biology, or related field.
- 24+ years in pharmaceutical QC under cGMP, aligned with FDA 21 CFR 210/211.
- 3Hands-on method development and validation, authoring protocols and writing reports.
- 4Sterility testing per USP , with validation for injections and suspensions; isolator experience preferred.
- 5Endotoxin testing per USP using kinetic chromogenic or turbidimetric methods.
- 6Microbial Limits Testing per USP for non-sterile products and raw materials.
- 7Subvisible particulate testing per USP with light obscuration and microscopy.
- 8Proficiency in media growth promotion and microbial identification.
- 9Strong aseptic technique and cell culture skills.
- 10Practical bioburden and sterility testing experience; knowledge of cGMP documentation.
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
Actalent
VerifiedMicrobiologist, Pharmaceutical Method Development
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.
GlaxoSmithKline
VerifiedQC Senior Scientist Microbiology, GMP Bioburden & BET
You will own microbiological testing for drug product, drug substance, and raw materials at GSK's Philadelphia site, ensuring release, in-process, and stability compliance. You will execute Bioburden and Bacterial Endotoxin Testing (BET), perform data review, and drive trend analysis. Operating on a Friday-Monday weekend shift, you will collaborate with Quality, Manufacturing, and Technical Operations while mentoring junior analysts. This role offers the chance to lead investigations, author SOPs, and serve as a microbiology SME, directly impacting regulatory submissions and inspections.
United Therapeutics
VerifiedQC Microbiologist, Environmental Monitoring & cGMP
You will own contamination control for cGMP manufacturing at our RTP facility, performing environmental monitoring and water sampling under USP and EP standards. You will ensure timely, accurate testing of materials to meet production demands. You will support all manufacturing operations, including process validation and utility systems sampling. You will troubleshoot instruments with the lab manager and manufacturer technical services. This role stands out by directly impacting patient safety through rigorous microbial testing and aseptic practices.
rapidmicrobio
VerifiedDirector Microbiology Rapid Micro Biosystems
Rapid Micro Biosystems seeks a Director Microbiology to lead strategic and operational microbiology initiatives driving innovation in healthcare product development. This fast-moving role offers high growth opportunities across global teams spanning robotics AI Machine Learning imaging microbiology and more shaping future pharmaceutical production. The position blends inclusive leadership with impactful contributions to scientific excellence.
Xttrium Laboratories Inc
VerifiedMicrobiology Technician, Environmental Monitoring & GMP
Own the microbiological quality program at a leading FDA-registered manufacturer of healthcare solutions. You will perform environmental monitoring, water testing, and post-cleaning verification across GMP production areas. Working with senior microbiologists, you ensure product safety for hospitals and pharmacies nationwide. This role offers direct impact on patient health through rigorous testing and documentation.
Transpire Bio
VerifiedDirector of Microbiology - Miami Biotech
Strategic leader driving microbiology operations for pharmaceutical product development. Oversee testing contamination control method development and regulatory compliance across clinical and commercial programs. Scale microbiology capabilities for late-stage development and IPO readiness.