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Staff Bioprocess Engineer, MSAT, Proteins

vaxcyte · Visp, Valais, Switzerland · Visp, Valais, Switzerland
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<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3> <div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. </div> <div> </div> <div><strong>WHAT</strong> we do is every bit as important as <strong>HOW</strong> we do it! Our work together is guided by four enduring core values:</div> <div> </div> <div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div> <div> </div> <div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div> <div> </div> <div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div> <div> </div> <div>*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3> <p>Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Protein Intermediates Staff Bioprocess Engineer. The incumbent will support the microbial manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at contract manufacturing organizations (CMO), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland, but will have responsibilities to oversee CMOs in Italy and Germany as well. </p> <p> </p> <p>This position will require the candidate to manage the highly complex microbial manufacturing processes for Vaxcyte’s vaccine portfolio. This is an exciting opportunity to join an outstanding team, with a mission to support late-stage clinical manufacture, launch, and commercial operations for the PCV franchise.  The successful candidate will have the following skills and qualities:</p> <ul> <li>A skilled process engineer with expertise in:</li> <li>microbial fermentation (cell expansion, fed-batch fermentation)</li> <li>primary recovery (centrifugation, diverse filtrations, precipitation)</li> <li>Purificatio<em>n (Ultrafiltration/Diafiltration and Chromatography)</em></li> <li>An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.</li> <li>The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders.</li> <li>A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind.</li> </ul> <h3>Essential Functions:</h3> <ul> <li>Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different polysaccharide intermediates required for Vaxcyte’s vaccine portfolio.</li> <li>Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.</li> <li>Enable MSAT DS team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting.</li> <li>Lead all aspects of and engage in the planning, design, execution, and documentation of Polysaccharides manufacturing process Investigations and CAPAs.</li> <li>Drive continuous improvement and change management in Polysaccharides manufacturing processes through technological innovation and application of first principles in process engineering.</li> <li>Support the process to select new CMOs and suppliers.</li> <li>Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies.</li> <li>Recommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement.</li> <li>Author and review technical reports, manufacturing documents, regulatory submissions, and publications.</li> <li>Present at department, project team, and senior management meetings. May present externally at scientific conferences.</li> <li>Support the CMOs during inspections of health authorities where necessary and ensure proper follow-up of any potential observation or recommendation.</li> </ul> <h3>Requirements: </h3> <ul> <li>PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 8+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochem

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