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 pneumococcal conjugate vaccine 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-XP, a PCV with an expanded breadth of coverage of greater than 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. 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 100 employees and anticipates continued, significant growth. On January 6, 2022, Vaxcyte announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for VAX-24, its lead vaccine candidate. The Company initiated the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and expects to announce Phase 2 topline immunogenicity, safety, and tolerability results by the end of the year. VAX-24 was designed to prevent 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-XP, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease.
- Support the development, implementation, validation (as required) and ongoing administrator support of LIMS (Laboratory Information Management System) and ELN (Electronic Lab Notebook) data systems as well as any statistical stability software interface required for charting and data analysis/trending purposes.
- Enable efficient work-flows to support the CMC team in easily entering and analyzing development data by building Benchling ELN data structures, templates, SQL queries and Insights dashboards.
- Ensure the proper entry, organization, retention, and reporting of CMC data generated for internal and external CMC development and manufacturing activities.
- Implement and maintain Vaxcyte data management policies, procedures, and requirements. Ensure data management processes and procedures are consistently followed across the CMC organization.
- Perform business administration and support functions related to workflow management, template creation, study set up, accounts and permissions management, configuration updates and testing in the ELN and LIMS systems.
- Assist with the development, implementation, and deployment of system training for users.
- Function as system superuser; provide operations support to end users and provide guidance in the implementation of LIMS/ELN functionality.
- Actively support the CMC team by uploading, entering, and verifying externally generated manufacturing in process, release and stability data with a focus on ensuring data accuracy.
- BA or BS degree in Computer Sciences, Biological Sciences, or related discipline or equivalent experience.
- Five years of experience in information systems management with at least two years of relevant experience in a laboratory setting in the pharmaceutical or biotechnology industry.
- Excellent understanding of data administration and management functions.
- Advanced knowledge of LIMS/ELN software required (experience with Benchling a plus).
- Basic knowledge of relational database concepts, schema design principles and SQL queries required.
- Proven track record in performing ELN/LIMS system troubleshooting and user support with exceptional customer service.
- Knowledge of various standalone lab instrumentation
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Detail-oriented with strong problem solving and decision-making abilities.
- Previous work in a regulated environment (FDA, EPA, etc.) is preferred, but not required.
- Working knowledge of MS Word, Excel, PowerPoint
- Exceptional teamwork skills required, with a strong customer-service orientation
- Excellent written and oral communication skills
- All Vaxcyte employees require vaccination against COVID-19
SVP of Program Management Location:
San Carlos, CA Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.