Senior Engineer, Device Development

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 a technically experienced and collaborative individual to join our Device Development Team to lead development of combination products in our portfolio through the development and regulatory stage gates required for commercial success and distribution. Initially, this candidate will support development and regulatory approval of VAX-31. About VAX-31: VAX-31 is an extremely complex biological vaccine whereby numerous (31) Drug Substances are presented as an adjuvanted suspension Drug Product (DP). The complexity of the DP necessitates careful consideration for development of a pre-filled syringe (PFS) combination product for clinical and commercial use. The VAX-31 DP is a suspension, which generates a unique set of challenges for production, handling, and testing. This is an SME position suited for someone who has experience in leading the technical combination product workstream for a PFS/biologic combination product. Experience with combination product design control requirements and generation of associated documentation is required. As a core member of the DP Technical Team, they will work closely with MSAT, CMO, Supply Chain, QC, QA and Clinical teams to ensure the appropriate Device Design requirements, including formal verification testing, are met for the product’s use in clinical studies and global marketing submissions. They will work closely with the Regulatory and Quality teams to ensure the appropriate 21 CFR Part 4- and 21 CFR Part 820.3-compliant documentation is produced to support clinical studies, marketing applications, and continued commercial life cycle management. This is a unique opportunity to be involved in arguably the most complex Drug Product to enter clinical testing and commercial readiness and be a crucial part of late-stage enablement and long-term commercial success, positively impacting millions of lives globally. Because of these complexities, experience in the vaccine space, particularly adjuvanted vaccines would be beneficial. Essential Functions: • Lead combination product and device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch, and post-market surveillance. • Guide the DP Technical Team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and 21 CFR Part 820.3, ensuring alignment and integration within established Combination Product program plans. • Develop and maintain design control documents and maintain the D