Director, Upstream Polysaccharide Process Development

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: The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Director/Associate Director with significant experience in early-stage fermentation development and late-stage Process Characterization (PC) to join the Polysaccharide process team. The candidate will take a leading role in designing upstream PC studies that will enable a timely and successful PPQ campaign. In addition, this person will organize, oversee and drive the upstream early phase pipeline programs. This is a critical role for the polysaccharide team which will require someone who is creative, flexible and can adapt in a fast-paced environment. 

Essential Functions:

• Develop and execute upon a high-level plan for validating the upstream commercial manufacturing process for the polysaccharide components of Vax-24.
•    Work with Process Development SMEs within the group and at CMO to complete risk assessments for critical process parameter identification.
•    Design process characterization studies to assess the criticality of parameters and manage a team to execute these studies.
•    Lead the authoring of PC reports and review PPQ protocols along with CMO counterparts.
•    Collaborate with CMOs to develop a validation plan for at-scale validation of the polysaccharide manufacturing process and drive the execution of that plan.
•    Work with internal stakeholders (e.g., Regulatory) to ensure that the Polysaccharide Upstream validation strategy fits within the program-wide strategy.
•    Collaborate with project management to maintain a detailed timeline for the activities that must be completed p