Sr. Scientist, Analytical Development

Location
San Carlos, California
Posted
May 10, 2022
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 pneumococcal conjugate vaccine 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-XP, a PCV with an expanded breadth of coverage of greater than 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. 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 100 employees and anticipates continued, significant growth. On January 6, 2022, Vaxcyte announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for VAX-24, its lead vaccine candidate. The Company initiated the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and expects to announce Phase 2 topline immunogenicity, safety, and tolerability results by the end of the year. VAX-24 was designed to prevent 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-XP, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease.
 
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 Funcitons:
    • 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 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 3+ years relevant industry experience; MS or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required.
    • Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track record of method development trouble shooting and validation.
    • Extensive hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates.
    • 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.
    • Self-starter; 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: Staff Scientist, Analytical Development
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Send resumes to:
careers@vaxcyte.com
 
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070