GSK · 6 hours ago
Principal Scientist, Microbiologist
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. The Principal Scientist, Microbiologist will provide microbiology and sterility assurance support to the R&D Sterile Manufacturing facility, ensuring patient safety, product quality, and data integrity through expertise in microbiological control and quality systems.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Oversee and develop improvements in training for sterility assurance of operators (aseptic practices, gowning, gloving)
Establish and maintain partnership interfaces with intra- and inter-departmental contacts (Manufacturing, Analytical Workstream Leads, Quality), Global Supply Chain, and Third parties to convey sterility assurance aspects of manufacturing
Recognize, communicate and lead investigation of aberrant microbiological test results or trends
Author microbiological methods and SOPs regarding sterility assurance
Author validation protocols and implement validation on instrumentation and test methodology
Investigate new technology in microbiological testing in line with GSK Microbiology Modernization initiatives
Actively prepare and support internal quality and external regulatory inspections
Perform, when appropriate, additional Quality Control activities, including: Environmental monitoring to support non-sterile and sterile areas and operations personnel Routine bioburden testing on raw materials and finished product, e.g., microbial enumeration, sterility testing, selected species testing Bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products Identifications of microbial isolates Approving test results that support release of finished products and stability programs
Ensure all necessary testing is performed and evaluated against specifications for drug products that will be used in the clinic
Adopt and drive adoption by others of data and digital tools to drive continuous improvement and deliver simplified, efficient business processes
Qualification
Required
BS (+5 years), MS (+3 years), PhD (+0 years) in Microbiology or a related field
Three or more year performing environmental monitoring to support non-sterile and sterile areas and operations personnel
Three or more years of experience performing routine bioburden testing on raw materials and finished product, e.g., microbial enumeration, sterility testing, selected species testing
Three or more years of experience performing bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products
Preferred
Three or more years of experience in pharmaceutical manufacturing
Experience working in aseptic environments
Experience training employees in Aseptic techniques
Company
GSK
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H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
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2026-01-08
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