- Job Type: Full-Time
- Function: IT
- Industry: Vaccine
- Post Date: 03/15/2023
- Website: www.vaxcyte.com
- Company Address: 353 Hatch Drive, Foster City, CA, 94404
- Salary Range: $224,000 - $240,000
About Vaxcyte
High-fidelity vaccines against pneumococcal infection and other bacterial infectionsJob Description
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 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. 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-XP, 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 Head of CMC IT Systems is accountable for Vaxcyte’s IT-managed CMC information systems, applications, tools, and analytics technologies. Utilizing expertise in both IT and Business Administration this position actively partners and collaborates with business leaders to derive and drive value from existing and new technology investments, including robust integrations and analytics capabilities. This role is responsible for recruiting, managing, and developing required resources (internal and external) who implement, support, and enhance our IT-managed CMC technologies. This is a hands-on role and reports to the Vice President of IT & Facilities at Vaxcyte’s San Carlos, California headquarters.
Essential Functions:
- Accountable for the delivery and management of CMC IT solutions including, but not limited to, Electronic Lab Notebook (ELN), Laboratory Information Management System (LIMS), Instrument Integrations, System Integrations (e.g., CMMS, 3rd party LIMS, JMP), Analytics.
- Manage technology-specific and matrixed teams who are responsible for the implementation, integration, validation (as required) and support of CMC IT systems.
- Collaborate with and provide solutions that drive value across multiple functions such as CMC, Lab Ops, Facilities, IT, Project Management, QA, Regulatory, etc.
- Partner with business leaders to prioritize IT investments aligned with business need.
- Assist with the creation and evolution of IT’s strategic and technology roadmap.
- Contribute to, and manage closely against, approved IT budget.
- Manage licenses and renewals of CMC and certain Research systems and tools.
- Establish standards including design patterns, master data and integration architecture.
- Provide functional and technical leadership to internal IT staff responsible for business administration and support functions of the CMC systems.
- Evaluate emerging technologies to support evolving business needs.
- Design systems and establish processes for proper data entry, organization, retention and reporting across internal/external process development, analytical development, and manufacturing activities.
- Implement, oversee, and ensure adherence to data management and governance policies, procedures and requirements that are consistent with Vaxcyte standards.
- Ensure monitoring technologies are in place for key systems.
- Facilitate and/or participate in system Change Review Boards.
- Develop and maintain system operational runbooks and KB repositories.
- Accountable for the development, deployment, and sustainment of system training for end users.
- Work closely with 3rd party partners to secure and streamline data transfers.
- Establish KPI’s to demonstrate system effectiveness and identify improvement areas.
- Participate in regulatory audits, as needed.
- Embrace and actively contribute to Vaxcyte’s fantastic culture.
Requirements:
- BA or BS degree in Computer Sciences, Biological Sciences, or related discipline.
- Minimum 10 years of IT/Business Administration experience in Life Sciences.
- People management experience required.
- Advanced knowledge of LIMS/ELN software (experience with Benchling a plus).
- Hands-on, working knowledge systems and tools including ERP, CMMS, EDMS, Chemical Inventory, Data Modeling, Data Acquisition, Analytics, and Informatics (e.g., JMP, Spotfire, ChemDraw).
- Background implementing and using integration technologies.
- Excellent understanding of data administration and management functions.
- Expert knowledge of relational database concepts and warehouse design.
- Experience leading system implementations (e.g., ELN and/or LIMS).
- Knowledge of risk-based software validation methods.
- Highly motivated individual and self-starter.
- Proven track record achieving results and meeting deadlines while working with internal and external cross-functional teams in a high-paced environment.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Vice President, IT & Facilities
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $224,000 - $240,000