QC Specialist II

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.

 

 

QC Specialist II 

 

Primary responsibilities include:

• Execute analytical methods/SOPs and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry.
• Monitor method performance, product quality, reagent usage, invalid rate and/or stability data.
• Support technical transfer of analytical methods, including comparability testing and co-qualification.
• Support 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 review of QC documentation and logbooks.
• Revise, and review SOPs, technical protocols, and technical reports.
• Support QC training activities.
• Support inspection readiness activities.
• Lead and participate on teams to support new processes and improve existing processes in the QC labs.
• Lead and support LEAN and 5S efforts as required.
• Perform other duties as required, including ad-hoc projects to support site and QC team objectives.

 

Requirements:

• Master’s or Bachelor’s degree in sciences and 2-4 plus years of experience in a GMP/QC lab setting
• Experience with safe lab practices and the handling of biological material
• Strong attention to detail and the ability to work cross-functionally
• Excellent communication and organizational skills
• The position will start as five eight-hour days but will move to four ten-hour days.

 

Preferred Requirements: