Sr. Director, ASAT for QC

Company Profile: Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com. Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard of care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults, and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies. Summary: Vaxcyte is looking for a highly skilled, motivated, energetic, and creative leader with extensive analytical develop experience to join Vaxcyte’s Analytical Development & QC organization as Senior Director of Analytical Sciences & Technology for QC. This role is highly technical, requiring in-depth scientific understanding of a broad array of analytical methodologies. This role has broad responsibilities, supporting all Process Development and Clinical Manufacturing functional areas, including Proteins PD/MFG, Polysaccharides PD/MFG, Conjugate Drug Substances PD/MFG, and Drug Product PD/MFG. Daily responsibilities require a blend of scientific problem-solving acumen, deep knowledge of Good Manufacturing Practices (GMP), and a strategic and dynamic business mindset. This role is not typical QC leadership, but more a counterpart of MSAT for all analytical activities in QC. The successful candidate will work collaboratively with a wide network of about 20 Contract Manufacturing Organizations (CMOs) and internal AD, PD, QC, MFG, Supply Chain, Program Management, CMC-Regulatory, and QA functional teams to drive excellence in analytical methods, including oversight of method transfer, implementation, and validation, as well as oversight of routine QC analytical lot release and stability testing at several CDMOs. The successful candidate will also be responsible for establishing reference standard programs for multiple analytical methods at CDMOs. Your mission is to pave the way for successful commercialization of Vaxcyte’s pneumococcal conjugate vaccines, VAX-24 and VAX-31. The successfully candidate will hold the end-to-end responsibility for all QC activities and deliverables within the company. You will be responsible for the oversight, implementation, and validation of a diverse range of 250+ analytical methods across a network of