About this role
<p>Shanghai, China | full time | Job ID: 11325 </p> <p> </p> <p> </p><p><span style="color:darkcyan"><strong>Position Summary:</strong></span></p> <ul> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and supportquality control for mAb and ADC projects.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">This role also involves supporting operational & troubleshooting activities on-site.</span></li> </ul> <p> </p> <p><span style="color:darkcyan"><strong>Your main responsibilities are:</strong></span></p> <ul> <li style="background-color:white;font-size:12.0pt;font-family:'Times New Roman', serif;text-indent:4.9333px"><span style="font-size:12.0pt;font-family:Arial, sans-serif;color:black">On-site operational support at collaboration partners and CDMOs for AS&Tand quality control to support analytical transfers (ad-hoc site visits for troubleshooting etc.) </span></li> <li style="background-color:white;font-size:12.0pt;font-family:arial, helvetica, sans-serif;text-indent:4.9333px"><span style="font-size:12.0pt;font-family:arial, helvetica, sans-serif">Review project documentation, including method development reports, analytical procedure protocols, method qualification/validation reports, according to regulatory guidelines</span></li> <li style="background-color:white;font-size:12.0pt;font-family:'Times New Roman', serif;text-indent:4.9333px"><span style="font-size:12.0pt;font-family:Arial, sans-serif;color:black">Independently drive assigned analytical packages within global technical operations</span></li> <li style="background-color:white;font-size:12.0pt;font-family:'Times New Roman', serif;text-indent:4.9333px"><span style="font-size:12.0pt;font-family:Arial, sans-serif;color:black">Ensure translation of technical documents for analytical transfer activities</span></li> <li style="background-color:white;font-size:12.0pt;font-family:'Times New Roman', serif;text-indent:4.9333px"><span style="font-size:12.0pt;font-family:Arial, sans-serif;color:black">Organization of technical visits at collaboration partners, CDMOs or vendors</span></li> <li style="background-color:white;font-size:12.0pt;font-family:'Times New Roman', serif;text-indent:4.9333px"><span style="font-size:12.0pt;font-family:Arial, sans-serif;color:black">Subject matter expert support for internal audits and Health Authority inspections</span></li> </ul> <p> </p> <p><span style="color:darkcyan"><strong>W</strong><strong>hat you have to offer:</strong></span></p> <ul> <li>Master’s degree or preferably PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment</li> <li>Proven experience in protein and ADC analytical technologies (physico-chemical assays, functional assays, quality control); knowledge in small molecule analytics is considered a plus.</li> <li>experience in analytical activities oflate-stage and commercial projects, including strategy definition and strategy execution, with a sound understanding of all stages in the drug development process. </li> <li>Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)</li> <li>Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders</li> <li>Excellent communication and negotiation skills as well as ability to communicate complex technical matters concisely to various stakeholders</li> </ul><p> </p> <p> </p> <p><span style="color:#3c9673"><strong>Apply now - We look forward to receiving your application!</strong></span></p> <p> </p> <p>Apply to our Shanghai, China location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).</p> <p> </p> <p>Job ID 11325 (please always specify if you have any questions)</p> <p> </p> <p>By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.</p> <p> </p>