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 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:
This role leads the supply planning team and has overall responsibility to ensure we have enough inventory to fulfill demand while minimizing write-offs due to product expiry. Role will have direct reports and be responsible for clinical and commercial products.
- Ensure we have feasible supply plans and maintain adequate inventory levels to meet our global commercial, clinical and development needs across the full breadth of our supply chain (critical raw materials, intermediates, Drug Substance, Drug Product and Finished Goods).
- Ensure that supply plans and safety stock targets adequately reflect risks related to demand, production performance, quality, shelf life and other key variables.
- Work cross functionally with program management, process development, quality, regulatory, commercial, finance, logistics, clinical supply and CMO / supplier management to ensure that supply plans are feasible.
- Determine capacity requirements for production and storage.
- Perform scenario planning as needed to support operational and strategic decision making.
- Lead efforts to determine optimum filling strategies, container sizes and production scales.
- Ensure we have robust tools for supply planning as our supply chain grows in complexity and we approach commercial launch.
- Lead the implementation of and serve as business owner for ERP processes related to inventory ordering and inventory management.
- Project costs of goods sold under multiple scenarios.
- Oversee activities to project inventory spend.
- Oversee activities to project expected inventory levels in terms of units, months on hand and value.
- Oversee creation of supply dashboards to help organization understand overall status and risk areas.
- Oversee provision of supply forecasts to suppliers and CMOs.
- Define and monitor KPIs including forecast accuracy, delivery performance, yield, and reject rate.
- Proactively identify potential supply risks and initiate actions to mitigate.
- Support the process to select new CMOs and suppliers.
- Support process to negotiate commercial supply agreements with CMOs and suppliers.
- Develop and own the commercial launch plan from a supply perspective.
- Design and Lead the Sales & Operations planning process as we approach commercial launch.
- B.S. / B.A. degree or Advanced Degree (preferred).
- 10+ years of experience working in pharmaceutical / biotech supply planning.
- Strong Knowledge of GMPs.
- Strong Experience leading Cross-Functional teams.
- Strong experience managing direct reports.
- Strong experience working with CMOs and Suppliers of pharma materials.
- Excellent analytic skills.
- Excellent communication skills.
- All Vaxcyte employees require vaccination against COVID-19.
Executive Director, Global Supply Chain Location:
San Carlos, CA Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range:
$197,000 - $234,000