Associate Director, Quality Assurance, CMO

Company: Vaxcyte Inc.
Location: San Carlos
Posted on: September 19, 2023

Job Description:

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, 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 .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.Essential Functions:

• Provide Quality Assurance oversight of Contract Manufacturing Organizations.
• Represent QA at internal cross functional team meetings and at CMO meetings.
• Lead batch disposition activities such as review of executed batch records, environmental monitoring and quality control data for conjugate drug substance production.
• Review and approve documentation such as master batch records, deviations, risk assessments, change controls, and CAPAs.
• Drive resolution of quality performance issues with the contract manufacturer.
• Support process characterization studies and validation activities.
• Develop, implement and maintain procedures and policies.
• Participate in risk assessments.
• Interact with key stakeholder to develop solutions to complex issues.
• Evaluate impact of deviations and change control.
• May participate in compliance audits as required.
• Promote a quality mindset and quality excellence approach to all activities.Requirements:
  • BS or BA with 10 years relevant industry experience.
  • Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines.
  • Knowledge and experience in Risk Management principles.
    • Knowledge in both clinical and commercial product desired.
    • Strong Management and process improvement skills.
    • Demonstrate excellent verbal, written, and interpersonal communication skills.
    • Demonstrate experience leading and contributing through influence and working in cross functional teams.
    • All Vaxcyte employees require vaccination against COVID-19.Reports to: Executive Director, Quality AssuranceLocation: San Carlos, CACompensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $182,000 - $192,000Send resumes to: Vaxcyte, Inc. 825 Industrial Road, Suite 300San Carlos, CA 94070We 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.

Keywords: Vaxcyte Inc., San Francisco , Associate Director, Quality Assurance, CMO, Executive , San Carlos, California