Associate Director, Quality Assurance, External Manufacturing

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 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.
Essential Functions: Perform quality assurance oversight of activities related to conjugate drug substance manufacturing.
Represent QA at internal and external cross functional team 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 internal and external documentation for compliance such as master batch records, deviations, risk assessments, validation protocols, change controls, and CAPAs.
Drive resolution of quality performance issues with contract service providers.
Support process characterization studies and validation activities.
Assess change control records to ensure changes are executed in a controlled and compliant matter.
Establish, review, and periodically update GMP related procedures and policies.
Participate in risk assessments.
Collaborate with key stakeholder to develop solutions to complex issues.
Lead quality investigations of deviations.
Identify and implement corrective and preventative actions.
Lead or assist in compliance audits as required.
Support process improvement initiatives.
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 Assurance Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $182,000 – $192,000 Send resumes to: careers@vaxcyte.
com Vaxcyte, Inc.
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.