Staff Engineer, Drug Substance, MSAT

Join our Mission to Protect Humankind! 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. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *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. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Drug Substance (DS) Staff Engineer. The incumbent will support the conjugation 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. This position will require the candidate to manage the highly complex conjugation 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: A skilled process engineer with expertise in: Molecule activation and bioconjugation (e.g., activation chemistries, conjugation reaction kinetics, in-process controls, and common side reactions/impurities) Strong quantitative skills: trend and multivariate analysis of process and analytical data to support continued process verification (CPV), deviation investigations, and process characterization (e.g., DOE). An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals. The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders. A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind. Essential Functions: 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 protein-polysaccharide conjugate Drug Substances required for Vaxcyte’s vaccine portfolio. Execute statistical thinking and data analysis using: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools. Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns. 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. Lead all aspects of and engage in the planning, design, execution, an…