Senior Specialist, Quality Control

Join our team of pioneers!

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.

 

 

Senior Specialist, Quality Control 

 

Primary responsibilities include:

• Support the day-to-day operation of the QC analytical lab to assure products met testing requirements, and laboratory operation and systems comply with regulatory requiremnts.
• Execute analytical methods/SOPs and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry.
• Subject matter expert of QC analytical methods in the areas of ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry
• Author and revise SOPs, test methods, technical protocols, and technical reports in compliance to cGMP
• Support routine record review of test data, logbooks and related documents associated with testing.
• Monitor method performance, product quality, reagent usage, invalid rate and/or stability data.
• Support technical transfer of analytical methods, including comparability testing, co-qualification, and full qualification of methods.
• Lead and author quality system records, including deviations, lab investigations, OOS, CAPA and change control. 
• Support QC equipment qualification for new lab equipment and perform routine maintenance of lab equipment and lab spaces.
• Support inventory and qualification of QC raw materials
• Train other QC staff on QC analytical methods and procedures.

•     Participate in regulatory inspection readiness activities, as required by Management

• Lead and participate in teams to support new processes, continuous improvement, LEAN and 5S efforts.

• Perform other duties as required, including ad-hoc projects to support site and QC team objectives.

 

Requirements:

• Bachelor’s degree in sciences with 6+ years of experience in a GMP/QC lab setting or
• Master’s degree in sciences wit