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Sr. Scientist, Analytical Development

Vaxcyte

San Carlos, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Industry: Vaccine
  • Post Date: 07/09/2024
  • 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.
 
Summary:
 
Vaxcyte is looking for an energetic and talented individual to join our analytical development team. The candidate will independently develop analytical methods (including but not limited to: different modes of chromatography, spectrometry such as MS, CE, colorimetric and light-scattering technique) and perform sample testing to support development and formulation of protein and conjugate vaccine targets. The successful candidate will also provide scientific mentorship and technical guidance for junior colleagues in analytical method development. Additional responsibility will also include analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer between our company and external partner groups.

Essential Functions:

    • Independently lead the development, qualification, and transfer of analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, and vaccine targets.
    • Develop analytical methods and conduct characterization studies to support raw material, formulation development and the establishment of appropriate manufacturing control strategies.
    • Perform analytical method transfer to CROs/CMOs.
    • Perform appropriate CRO/CMO oversight by reviewing analytical method development data, reviewing and approving analytical method validation protocols and subsequent reports, and reviewing and approving analytical method SOPs.
    • Provide technical oversight to drug substance/drug product release and stability testing, as well as trouble shooting and analytical investigation at CRO/CMOs.
    • Author protocols, reports, and regulatory submissions as appropriate.

Requirements:

    • PhD in Chemistry, Analytical Chemistry preferred, Organic / Biochemistry considered, with 5+ years relevant industry experience; MS with 8+ or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required.
    • Ideal candidate will have a strong theoretical understanding and extensive hands-on experience of SEC-MALS technique. Familiar with Wyatt instrument and ASTRA software is a plus.
    • Broad hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates and successful track record of method development trouble shooting and validation, e.g., UV-Vis, various modes of HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
    • Self-starter; able and willing to learn new techniques quickly and work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
    • Direct experience operating Agilent HPLC using OpenLab/ Chemstation software and/or Waters UPLC and Empower software for data acquisition and analysis.
    • Experience working in a regulated (GLP / GMP) environment.
    • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation for small molecules, biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy.
    • Attention to detail and excellent skills in record keeping / documentation.
    • Extensive technical writing experience in drafting method protocols, SOPs and reports.
    • Project management skills including the ability to manage one’s project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
    • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
    • Constantly identify gaps and areas for improvement and escalate to management as appropriate.
    • All Vaxcyte employees require vaccination against COVID-19.
Reports to: Associate Director, Analytical Development Characterization and Early Development
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $145,000 – $162,000
 
 
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.