Investigator, Microbiology and Sterility Assurance

Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Jul 25 2023

Are you energized by a highly impactful microbiology role that allows you to accelerate translational medicine and shape scientific research? If so, this Microbiology Manager role could be an exciting opportunity to explore.

As an Investigator on the Microbiology team supporting sterility assurance and Microbiology testing for a R&D Sterile Manufacturing facility, this role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

•

• Participate in evaluating new equipment and new technology for a new R&D sterile manufacturing facility.
• Lead and participate in risk assessments related to Microbiology and sterility assurance.
• Achieve and maintain Grade B gown qualification status in the sterile facility.
• Provide direct Microbiological support and oversight for aseptic process simulations and sterile filling operations.
• Provide sterility assurance support to the R&D Sterile Manufacturing facility for all product, people and material processes related to contamination control.
• Recognize, communicate and lead investigations of aberrant microbiological test results or trends
• Write microbiological methods and SOPs regarding sterility assurance where required
• May be required to perform Microbiological Quality Control activities, including:
  • Environmental monitoring to support non-sterile and sterile areas and operations personnel
  • Aseptic sampling and testing of pharmaceutical water system samples
  • 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

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Microbiology is preferred, or related science,
• Demonstrated experience of a microbiologist in a product Quality Control role
• Demonstrated experience of cGMP requirements and ability to generate high quality data
• Computer application experience (i.e., database use and management)
• 3 years demonstrated laboratory experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Demonstrates good communication skills
• Master’s degree in Microbiology is preferred, or related science, and demonstrated abilities and experience of a microbiologist in a STERILE product Quality Control role
• Recent experience in aspects of sterility assurance including gowning and investigations
• Experience evaluating sterility assurance aspects of new equipment and new technology for sterile manufacturing.
• Experience leading and participating in risk assessments related to Microbiology and sterility assurance.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

#LI-GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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