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Quality Control Manager

Vaxcyte

San Carlos, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Industry: Vaccine
  • Post Date: 04/15/2024
  • Website: www.vaxcyte.com
  • Company Address: 825 Industrial Rd, Suite 300, San Carlos, California 94070, US

About Vaxcyte

Vaxcyte 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

Job Description

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:

    • Collaborate with CMOs to ensure release testing requirements are being met at the agreed upon timelines.
    • Review and approve specification documents, Certificates of Analysis and release reports from CMOs. May need to author internal SOPs related to Quality Control policies and procedures.
    • Generate Internal CoAs and CoTs and trend release results and system suitability criteria
    • Apply technical expertise to the review of method validation, transfer and release documentation.
    • Manage sample submission forms, shipping and sample handling activities required between the CMOs to support on time validation, testing and release of Vaxcyte components.
    • Responsible for execution of quality control testing and supportive processes including sample /inventory management, scheduling, documentation, compliance review, results reporting (CoA), and scientific interpretation of data / method performance to ensure high quality data and control of methods.
    • Responsible for quality event management (deviations, investigations, change control) related to QC operations.
    • Support audits, inspections, and health authority responses.
    • Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
    • Provide strong teamwork in establishing a quality culture and shared accountability.
    • Collaborate with ADQC and interface with key stake holders to understand methods being performed onsite and at CMOs. 

Requirements:

    • MS or BS with 7-10/years of industry experience in Pharma / Biotech industry required.
    • Understanding of various analytical chemistry methodology principles and experience with method transfer, trouble shooting, validation and/or GMP release testing.
    • Have solid understanding of various analytical technology used for analysis of proteins, conjugates, small molecules, and other large molecules. Able to apply the knowledge and gain an in depth understanding of variety of methods in place for components used in Vaxcyte vaccine programs.
    • Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards.
    • Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
    • Awareness of relevant FDA, EU, and ICH regulatory guidelines as applicable to QC operations related to small molecules, biologics and vaccines, and expiry dating.
    • Understanding of how regulatory guidance shapes industry approaches to phase appropriate analytical transfer, validation strategies, and QC practices.
    • Self-starter and resourceful problem solver, able to move up learning curve with some guidance and map out intermediate milestones to achieve personal goals.
    • Technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOP preferred.
    • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
    • Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
    • All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Manager, Quality Control Method Validation & Transfer
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $150,000 – $168,000
 
 
Send resumes to:
 
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.