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Senior Manager* Late Stage RNA Process Development

BioNTech SE
Germanyfull_timeVerifiedPosted 4 Sept 2024

About the role

<p></p> <p> </p> <h3><span><span><b><span>Join our team of pioneers!</span></b></span></span></h3> <p><span><span>As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.<br/>  <br/> We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.</span></span></p> <p><br/>  </p> <p><span><span><span><span><b><span><span><span>Senior Manager* Late Stage RNA Process Development</span></span></span></b></span></span></span></span><b><span><span> </span></span></b></p> <p> </p> <p><span><span><span><span>At BioNTech you will support our RNA process development team and contribute as part of an interdisciplinary team to the development and characterization of processes for RNA manufacturing and to actively shape development projects towards clinical phases and commercial production.</span></span></span></span></p> <p> </p> <h3><span><span><b><span>Your main responsibilities are:</span></b></span></span></h3> <p> </p> <ul> <li> <p><span><span><span><span><span>Set-up of concepts </span></span><span><span>for late-stage process development and characterization for </span></span><span><span>RNA synthesis and RNA purification</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Small-Scale Model Strategy and Qualification</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Implementing Quality by Design (QbD)-based RNA process characterization</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Harmonization of process control strategies and comparability </span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Support qualification and validation strategies</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Documentation set-up and alignment for harmonized rapid process transfers &amp; CMC documentation</span></span></span></span></span></p> </li> </ul> <p> </p> <p><span><span><b><span>What you have to offer:</span></b></span></span></p> <p> </p> <ul> <li> <p><span><span><span><span><span>Degree in natural sciences (ideally PhD)</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Longterm experience (&gt;3) in late-stage process development and technology transfer, desirably with knowledge in the GMP area</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Working familiarity with preparative and analytical purification methods (such as FPLC, Diafiltration, capillary electrophoresis) is desired</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Experience <em>in vitro</em> RNA synthesis, RNA purification and analytics is preferred</span></span></span></span></span></p> </li> <li> <p><span><span><span><span>Strong experience in setting-up QbD (Quality-by-design)</span></span></span></span></p> </li> <li> <p><span><span><span><span>Relevant knowledge in statistical experimental design and data analysis (DoE)</span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Conscientious, precise, and independent way of working</span></span></span></span></span></p> </li> <li> <p><span><span><span><span>Excellent communication skills </span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Commitment and the ability to find your way in a fast-paced and interdisciplinary environment.</span></span></span></span></span></p> </li> <li> <p><span><span><span><span><span>Fluent in english and german</span></span></span></span></span></p> </li> </ul> <h3><br/> <span><span><b><span>Benefits for you:</span></b></span></span></h3> <ul> <li> <p><span><span>Flexible Working Time</span></span></p> </li> <li> <p><span><span>Mobile Office</span></span></p> </li> <li> <p><span><span>Work from EU Countries (up to 20 days per year)</span></span></p> </li> <li> <p><span><span>Company Pension Scheme</span></span></p> </li> <li> <p><span><span>Childcare</span></span></p> </li> <li> <p><span><span>Jobticket</span></span></p> </li> <li> <p><span><span>Company Bike</span></span></p> </li> <li> <p><span><span>Leave Account</span></span></p> </li> <li> <p><span><span>Fitness Courses</span></span><br/>  </p> </li> </ul> <p><span><span>... and much more.</span></span><br/>  </p> <p> </p> <h3><span><span><b><span>Have we kindled your pioneering spirit? </span></b></span></span></h3> <p> </p> <p><s

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BioNTech SE

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