Principal Scientist, Microbiologist

Principal Scientist, Microbiology

This position will initially be located at the GSK’s Upper Merion site in Upper Merion, Pennsylvania from 2025 to 2027/2028, and will permanently move to Marietta, Pennsylvania afterwards.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
 

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Provides microbiology/sterility assurance support to the R&D Sterile Manufacturing facility in Upper Merion, PA and Marietta, PA for all product, people and material processes related to contamination control. This includes providing expertise in microbiological control of materials, processes and people for sterile and non-sterile clinical supply manufacturing in accordance with GMP requirements and corporate policies and standards to ensure patient safety, product quality and data integrity.

In addition, the sterility assurance microbiologist contributes to the development and implementation of quality systems (where they relate to microbiological design and safety), microbiology modernization and application of digital data activities in support of support of operational efficiency.

Key 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

Basic Qualifications:

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 Qualifications:

• Three or more years of experience in pharmaceutical manufacturing.
• Experience working in aseptic environments.
• Experience training employees in Aseptic techniques.

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