Microbiologist I Quality Control Microbiology

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Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.

 

 

Microbiologist I Quality Control Microbiology 

 

This position is located at the BioNTech Gaithersburg, Maryland, GMP manufacturing site.  The Gaithersburg site includes functions supporting cell and gene therapy research, development, and GMP manufacturing operations.  These collective functions result in a collaborative environment that is aligned from drug discovery to GMP release of drug product for our patients.   

 

The QC Microbiologist I (as experience allows) is responsible for partnering with managers and subject matter experts in leading, supporting, and maintaining QC microbiological functions and contamination control for new and existing GMP manufacturing operations. 

 

Primary responsibilities include:

• Support facility qualification operations for new GMP manufacturing areas, including Environmental Monitoring Performance Qualification (EMPQ) and GMP utilities qualification.
• Perform environmental monitoring (EM) of GMP classified cleanrooms. 
• Perform sampling and testing of GMP utilities, including purified water and clean gases.
• Perform microbiological assays and operations such as Rapid Sterility, Rapid Endotoxin, Gram Stain, Microbial Identification, Growth Promotion, Bioburden, and plate reading.
• Review QC raw data, such as testing and logbooks. 
• Support data management requirements for the team, including data entry and data verification, trending of data, and authoring of trend reports, utilizing Excel, LIMS, or other trending software.
• Perform routine maintenance of lab equipment and lab spaces.
• Conduct investigations for procedural deviations, out of specifications (OOS), and environmental monitoring / clean utility excursions.  Determine and execute corrective and preventative actions (CAPA) as determined for investigations, excursions, and OOS. 
• Support QC equipment qualification, including implementation of new rapid QC methods.
• Perform method qualification to support of sterility and endotoxin testing. 
• Develop, revise and review SOP’s.
• Identify, author, and review change controls for the QC team.
• Lead and support continuous improvement projects such as rapid testing technology, automated testing technology, technical QC studies, LEAN, and 5S.

What you have to offer. 
Requirements:

• Bachelor’s or Master’s degree in the sciences and 0-2 years of experience in a GMP lab setting, preferably in a  QC Microbiology lab setting, or suitable coursework in Microbiology.
• Experience using micropipettes for aseptic fluid transfers.

• Experience with safe lab practices and handling of biological material.
• Experience in aseptic technique and behaviors, such as those required for GMP gowning and in GMP clean rooms.
• Excellent interpersonal, verbal and written communication skills.

• Ability to organize workload and work independently and collaborate within teams, as needed, for timely completion of objectives.
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
• Ability to lift 25 lbs.
• Proficient in MS Word, Excel, and Power Point.

 

Preferred Requirements:

• Knowledge of GMP