Senior Director, Manufacturing Engineering and Facilities
Sales & Business Development, Operations
San Carlos, CA, USA
Posted on Thursday, October 5, 2023
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.
As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is initiating development of dedicated biologics manufacturing facilities. This position will be responsible to support all aspects of strategic and operational activities related to GMP Manufacturing Engineering and Facilities. The strategic activities will include development of manufacturing network strategy, site selection process, facility due-diligence, regulatory and governmental interfaces, and facility acquisition. From an operational standpoint, this position will lead Vaxcyte’s Manufacturing Engineering and Facilities management including design, construction, startup, validation, and licensing. This position will be responsible for overseeing a portfolio of capital projects around the world.
Working closely with Process Development, Quality, Manufacturing, and Regulatory functions; this position will oversee facility build/upgrade projects and drive implementation of the global manufacturing network strategy. This role will be critical to timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. It is necessary to possess solid knowledge of GxP (GMP, GLP, GCP) regulations. Solid expertise in global engineering and facilities, cross-functional teamwork, and building successful organizations is paramount in this role. This position will report to the SVP Commercial Manufacturing & Supply Chain.
- Provide leadership, strategic direction, risk assessment and oversight for translation of the corporate strategy into supportive strategies for global manufacturing.
- Represent the company on critical and confidential projects and provide recommendations.
- Lead State and local agency discussions in areas of economic development, growth, and expansion.
- Develop and maintain site master plans and oversee facility expansion and modification products including planning, design, construction, qualification, and operational readiness.
- Lead the internal project team for design and construction of new facilities.
- Responsible for various sub functions within Manufacturing Engineering and Facilities, areas including Maintenance, Engineering, Calibration, Automation, Equipment Validation, Site Services, and EHS; to allow Vaxcyte to grow globally and become a leader in bacterial vaccines.
- Create and monitor key performance indicators, highlighting progress, risks, and mitigation options.
- Collaborate closely with Executive Team, Functional/Department Heads, and project team members.
- Coordinate resource planning across programs to ensure adequate resources are available, escalate and resolve issues.
- Proactively identify and quickly resolve issues and problems.
- Bachelor's Degree in Engineering, MS Degree in Engineering or MBA preferred.
- 10+ years of professional management experience in leading GMP plants, facilities, engineering and/or other large operations.
- Demonstrated ability to work effectively at all levels of an organization.
- Successful facility start-up and commercialization experience.
- Strong organizational, management, teamwork, interpersonal skills, and professionalism required.
- Proven leadership for the creation of a robust, scalable, and compliant manufacturing facility, processes, and systems.
- Proven leadership in the development and mentoring of staff.
- Proven experience in managing engineering of Large Molecule GMP manufacturing facilities, microbial manufacturing experience desirable.
- Demonstrated experience in establishing Quality and Safety mindset/behaviors and a culture of continuous improvement.
- Relentless focus and passion around process improvements (efficiency and automation).
- Financial acumen, experience in creating, managing, and adhering to budgets.
- Ability to balance, prioritize, and resolve conflicts.
- Manage multiple projects in a fast-paced environment.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Vice President, Commercial Manufacturing & Supply Chain
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $254,000 – $272,000
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.