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SalaryCompany 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.
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 manage and provide scientific mentorship and technical guidance for junior scientists 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:
- Lead complex, strategic development projects with significant impact on company goals.
- Effectively lead a small team and develop team members.
- 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.
- Collaborate with cross-functional teams like QC, Stability, PD, Formulation groups and deliver high quality analytical results in a timely manner to enable informed decisions.
- Develop analytical methods and conduct characterization studies to support raw material, formulation development and the establishment of appropriate manufacturing control strategies.
- Innovate and implement new analytical strategies.
- Oversee the scientific aspects of analytical chemistry and documentation, ensuring scientific rigor and regulatory compliance, and enhancing efficiency and effectiveness.
- Provide leadership and mentorship within the scientific team and across the organization.
- Responsible for guiding the development of junior scientists and managing team dynamics.
- Act as a key scientific advisor for strategic decision-making processes.
- Involve in high-level strategic decision-making that affects the direction of Analytical Development, compliance, and technology adoption.
- Assess risks and make decisions that balance innovation with practicality, considering the regulatory and competitive landscape.
- Perform analytical method transfer to CROs/CMOs.
- Provide technical oversight to drug substance and stability testing, as well as trouble shooting and analytical investigation at CRO/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.
- Author protocols, reports, and regulatory submissions as appropriate.
Requirements:
- PhD in Chemistry, Analytical Chemistry preferred, Organic / Biochemistry considered, with 7+ years relevant industry experience; MS with 12+ years of industry experience; (Pharma / Biotech / Analytical Testing) required.
- Strong leadership skills and experiences of managing direct reports.
- Expert in analytical method development, validation, and troubleshooting.
- Deep understanding of regulatory guidelines and quality assurance standards (FDA, EMA, ICH).
- Skilled in the latest analytical technologies and methodologies 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, SEC-MALS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
- Capable of making critical decisions under pressure, especially when experiments or projects do not go as planned, ensuring minimal negative impact on the organization’s goals.
- 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.
- Communicate strategically, aligning their messaging with organizational goals and priorities. This includes influencing senior management and external stakeholders.
- Play a crucial role in mentoring others not just on scientific matters but also in effective communication and professional development.
- Must effectively communicate across the organization and with external partners, including regulatory bodies, to drive forward the scientific and strategic agenda.
- Attention to detail and excellent skills in record keeping / documentation.
- Extensive technical writing experience in drafting method protocols, SOPs and reports.
- Experience working in a regulated (GLP / GMP) environment and experience with DOE using JMP is a plus.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Associate Director, Analytical Development
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $169,000 - $185,000
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.
