Sr. Manager, Pilot Plant Operations, Protein Development and Clinical Manufacturing

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: We at Vaxcyte Inc, are looking for a Sr. Manager of Pilot Plant Development Operations to come in and lead the design, commissioning and operation of a new state-of-the-art pilot facility. This facility will serve as a major technical hub of the business and will support execution of process characterization, validation studies as well as new technology evaluations as deemed necessary. Once the facility is online, the candidate will be leading routine pilot plant operations for a team that you hire and build and will be responsible for future plant expansion projects.

Essential Functions:

• Serve as the technical expert and hands-on project leader from sign and specification stages, through commissioning and operations.
• Define the requirements of the new pilot plant, create all project documentation and plans, monitor progress, resolve technical issues, and ensure compliance with relevant regulations.
• Build a strong team of technical experts to manage routine operations in the Pilot Plant.
• Collaborate with suppliers, architects, and facility engineers to ensure designs and equipment align with the project goals and requirements.
• Define the budget, then specify and procure necessary equipment and capabilities.
• Manage the new facility and lead a team of plant operators and engineers.
• Represent Pilot Plant Operations at CMC meetings and with external partners including CDMO as appropriate.
• Model behaviours of ownership and accountability; hold a strong commitment to Vaxcyte’s mission of protecting humankind.

Requirements:

• B.S degree in a science or engineering discipline with 10+ years' experience in Biotech/Pharmaceutical industry focused in Process Development/Clinical Manufacturing and evolving to technical leadership in the design of