Senior Manager, Process Validation MSAT Protein Sciences

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:
This senior level position will provide process validation leadership for vaccine drug substance manufacturing processes. The position leads and/or participates in the planning, preparation, execution, and summarization of process validation activities in the Protein Sciences Department as part of the company’s overall process validation program. The role also provides input into validation assessments supporting investigations, change controls, and periodic reviews associated with the process validation lifecycle for a manufacturing process/product. The incumbent should be able to execute work independently, work with various groups across the organization, coach junior level staff members and/or contractors, be a self-starter, and be able to oversee, lead projects and teams.

Essential Functions:

• Leading process validation activities: defining PV strategies in a process validation master plan.
• Generating protocols, evaluating data, and writing final reports (PPQ, filter qualification, media/buffer mixing, column or membrane cycling, hold time, etc).
• Process validation sampling oversight or coordination.
• Generating of regulatory submission document subsections.
• Project management of overall and individual PV projects and activities.
• Authoring validation impact assessments for investigations.
• Authoring justifications for the assessment of change controls for process impact.
• Ability to manage multiple projects and activities of moderate complexity simultaneously.
• Liaise with functions such as Development, Manufacturing, Supply Chain, Project Management, QA, QC, and Regulatory Affairs as well as off-site functions such as external partners.
• Support regulatory inspections through the preparation, defense, and interaction with auditors in areas r