Skip to main content

This job has expired

You will need to login before you can apply for a job.

Staff Scientist, Analytical Development

Employer
Vaxcyte, Inc.
Location
San Carlos, California
Start date
Apr 3, 2024

View more

Job Details

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. 

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
 
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 Early Characterization & Early 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
 
 

Company

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.

Company info
Website
Phone
(650) 837-0111
Location
825 Industrial Road, Suite 300
San Carlos
CA
94070
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert