Research Associate, Analytical Development

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.

 

 

Research Associate, Analytical Development 

 

We are seeking a Research Associate to join the Analytical Development team responsible for the Phase Appropriate development of cGMP release & stability methods to transfer to the Quality Control division for clinical manufacturing.  This role will also be responsible for developing characterization assays, sample testing for process development, writing SOPs & technical reports, method co-qualification, and more within the autologous cell therapy division.   

 

The focus will be on the development of potency and cell-based methods including cytokine release and cell killing assays.  Solid cell culture experience is required while other techniques can be trained and developed. 

 

Requirements:

• BS or MS in a biotechnology related field (biochemistry, chemistry, molecular biology, biology) with a minimum of 2 years’ experience in a GMP industry setting performing development.
• Experienced in mammalian cell culture (adherent and suspension), aseptic technique, and preferably immunoassays (such as ELISA).
• Some knowledge of ICH guidelines required for method development.
• Ability to design, execute, and troubleshoot method development activities including statistical analysis of data with moderate guidance and direction from manager.     
• Solid technical writing and verbal communication skills are imperative for the responsibilities of document writing and data presentations. 

Preferred Requirements:

• Experience in potency assays is a plus.
• Knowledgeable in Design of Experiments (DoE), JMP software and/or other statistical tools used for method development activities is a plus.   
• Positive can-do attitude and growth capabilities.    
• Ability to rapidly adjust to changing priorities and timelines, learn new skills and stretch abilities.   

 

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Benefits for you:
 

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: