Principal Scientist, Microbiologist
Listed on 2026-02-07
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Healthcare
Principal Scientist, Microbiology – This senior role will provide microbiology/sterility assurance support for GSK’s R&D Sterile Manufacturing facilities in Upper Merion, PA and Marietta, PA. The position focuses on ensuring contamination control for sterile and non‑sterile clinical supply manufacturing, advancing quality systems, supporting modernization initiatives, and providing expertise during audits and inspections.
Key Responsibilities- Develop and improve training for operators in aseptic practices, gowning, and gloving to support sterility assurance.
- Maintain partnership interfaces with manufacturing, analytical workstream leads, quality, supply chain, and third parties to communicate sterility assurance requirements.
- Investigate and lead resolution of abnormal microbiological test results or trends.
- Author microbiological methods and SOPs related to sterility assurance.
- Develop validation protocols and implement validation on instrumentation and test methods.
- Explore new microbiological technologies aligned with GSK Microbiology Modernization initiatives.
- Prepare for and support internal quality and external regulatory inspections.
- Perform additional quality control activities, including:
- Environmental monitoring for non‑sterile and sterile areas.
- Routine bioburden testing on raw materials and finished products.
- Bacterial endotoxin testing on pharmaceutical water system samples.
- Identification of microbial isolates.
- Approval of test results supporting product release and stability programs.
- Ensure all required testing is conducted and evaluated against specifications for clinic‑grade drug products.
- Promote adoption of data and digital tools to drive continuous improvement and simplify business processes.
- BS (+5 years experience) or MS (+3 years experience) or PhD (+0 years experience) in Microbiology or a related field.
- Minimum 3 years performing environmental monitoring in sterile and non‑sterile environments.
- Minimum 3 years performing routine bioburden testing on raw materials and finished products.
- Minimum 3 years performing bacterial endotoxin testing on pharmaceutical water system samples, raw materials, and finished products.
- Minimum 3 years of experience in pharmaceutical manufacturing.
- Experience working in aseptic environments.
- Experience training employees in aseptic techniques.
GSK is an Equal Opportunity Employer
. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or military service.
If you require assistance in demonstrating your strengths and capabilities, contact us at For more information, please visit the GSK US Benefits Summary to learn more about our comprehensive benefits program.
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