Senior Specialist Engineering - Large Molecule Technical Operations Site Support

<p>Job Description</p><p></p><p><span><b><span>Large Molecule Technical Operations Site Support (LMTO SS) </span></b></span><span><span>is a team<b> </b>that provide skills and expertise to all the Large Molecule manufacturing sites (both internal and external) within our Manufacturing Division. Our</span></span><span> <span>mission is to establish new capabilities and processes that significantly improve manufacturing productivity and technical effectiveness of LM sites and technical support teams, ensuring successful project and manufacturing execution. </span>Our team routinely supports athe manufacturing facilities in activities such as technology transfer, authoring site-based documentation, leading manufacturing investigations and trend evaluations, developing and introducing process enhancements, and providing project leadership.</span></p><p></p><p>Given the diverse roles that will played by the successful candidate, the role requires high levels of flexibility, adaptability, innovation, enthusiasm and a broad technical knowledge. This is a unique opportunity to support a broad range of the large molecule manufacturing business with the role working across drug substance, drug product, internal and external manufacturing for both biologics and vaccine manufacturing modalities. The successful candidate will gain a vast array of experience in different areas across the large molecule business in this role.</p><p><span> </span></p><p><span><span>As our team is growing, we are hiring a <b>Senior Specialist</b> to join our team of scientists and engineers. You will report directly to a LM technical lead in the EU and will support the large molecule business both regionally and to the and broader global network. </span></span><span>Given the diverse roles that will played by the successful candidate, the role requires high levels of flexibility, adaptability, innovation, enthusiasm, and a broad technical knowledge base across multiple different areas. <span><span> </span></span>The position will be located at one of our company's sites and will involve primarily working remotely from a site but with flexibility to work virtually. <span>You may be required to be available to travel to sites within Europe and/or North America, at approximately 10-25%.</span><span> </span></span></p><p></p><p><b><span>What</span> you will do: </b></p><p>Bring energy, knowledge, innovation and leadership to carry out the following:</p><ul><li><p>Provision of direct support to drug substance and/or drug product manufacturing sites</p></li><li><p>Strategic project leadership for multi-site technical or continuous improvement initiatives</p></li><li><p>Supporting and/or leading technology transfer activities at our manufacturing nodes</p></li><li><p>Facilitation and leadership of quality risk assessments and after-action reviews</p></li><li><p>Leading and/or supporting complex and/or multi-site investigations</p></li><li><p>Ensuring best practices are documented, communicated and implemented across manufacturing nodes</p></li><li><p>Leading and/or supporting supplier related technical issues</p></li><li><p>Support of inspections at manufacturing nodes</p></li><li><p>Authoring, reviewing regulatory documents and supporting regulatory responses</p></li><li><p>Authoring, reviewing and approving technical study protocols, memos and reports</p></li><li><p>Support person-in plant activities for technology transfer and lifecycle management changes</p></li><li><p>Actively participates in a culture of continuous improvements and process optimization</p></li><li><p>Providing technical direction in the interpretations of trends observed in process monitoring and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.</p></li></ul><p><span> </span></p><p><span><b><span>Is this the role for you?</span></b></span><span><span> </span></span></p><p><span><span>Are you someone who enjoys working in a diverse role?  Do you have experience in large molecule manufacturing and GMP operations? </span></span><span><span>Are you interested in expanding your skillset into multiple different areas of the large molecule manufacturing business?</span></span></p><p></p><p><b>Skills/Experience</b></p><p>The successful candidate should have the correct blend of education, skills, experience and positive energy to meet the diverse needs of the role</p><p>Key elements of this role include supporting team/partner interactions, supporting change management, <span><span><span>deviations/investigations,</span></span></span> and supporting continuous improvement initiatives.</p><p></p><p>In order to excel in this role, <b><u>the ideal candidate will </u></b>have:</p><ul><li><p>A BSc, MSc or PhD in a science or engineering field ideally specializing in the life sciences areas</p></li><li><p>Have a deep understanding of the science and technology behind large molecule manufacturing processes</p></li><li><p>P