Associate Director, CMC Project Management
San Carlos, CA, USA
Posted on Wednesday, January 10, 2024
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.
- Provide, and lead a team of project managers in providing, CMC Project Management for both internal and external CMC development and manufacturing activities to ensure deliverables are achieved on time, within scope, and on budget.
- Hire, train, and manage CMC Project Management team members to ensure project management support is successfully provided to CMC teams for projects ranging from pre-IND through clinical development and commercialization.
- Develop detailed timelines for CMC component project plan, identify risks and mitigating actions and communicate/escalate accordingly to ensure clarity of deliverables and timing to achieve overall product/project plan and corporate goals/objectives.
- Lead CMC cross-functional coordination meetings, including scheduling and facilitating meetings, sending out agendas, writing and distributing meeting summaries, managing team documentation, and tracking goals and action items.
- Ensure operational plans are proactively tracked and highlight progress towards key milestones to ensure alignment of task dependencies associated with internal and external development and manufacturing activities. Responsible for efforts associated with process development, analytical development, manufacturing, quality, and supply chain.
- Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule.
- Communicate with appropriate stakeholders to ensure project team and leadership are fully informed and knowledgeable of project activities, status, and potential risks.
- Contribute to program cross-functional working plans and timelines, help teams prioritize workstreams, proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals.
- Build and manage trackers and dashboards to communicate real-time status of projects related to campaign manufacturing and analytical readiness, release and downstream use.
- Manage external CMOs through development of Statements of Work (SOW) contracts. Provide initial screening and work with Program Manager and internal technical subject matter experts, legal, and finance, as required, to define scope and budget.
- Identify processes/tools to continuously improve and streamline the workflow of CMC project management and coordination teams. Responsible for implementing shared tools and processes across the CMC Project Management team and the cross-functional CMC project teams.
- As a leader within the CMC Project Management team, you will play a key role in maintaining project management excellence. This includes collaborating on best practices, standardizing team management operations, maintaining alignment of program dashboards, and leading initiatives that enhance the program support we provide the CMC cross-functional organization.
- BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
- PMP Certification and/or Project Management training desired. Project Management experience required.
- Eight plus years of experience in the pharmaceutical or biotechnology industry with at least five years of relevant experience in a CMC organization, including significant experience in a cross-functional team environment.
- Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations. Previous experience supporting regulatory filings a plus.
- Direct experience leading and managing high-performing teams.
- Prior experience as a liaison with external manufacturing organizations strongly desired.
- Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes, and budgets.
- Expert analytical skills for integrating and interpreting interdisciplinary project information.
- Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
- Demonstrated ability to lead other project managers in managing complex projects independently and managing changes in processes, strategy, and competitive landscape.
- Strong team management skills, including facilitation, conflict resolution, and team development.
- Proven influence management and communication skills, at all levels of the organization.
- Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project.
- Working knowledge of Veeva and Smartsheet a plus.
- Excellent written and oral communication skills.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Executive Director, CMC and General Project Management
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $190,000 - $195,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.