Staff Scientist, Analytical for Protein Development and Clinical Manufacturing
San Carlos, CA, USA
Posted on Monday, September 25, 2023
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.
Vaxcyte is looking for a highly skilled, motivated, and creative analytical scientist to join Vaxcyte’s Vaccine Product Development organization as staff scientist within Protein Development and Clinical Manufacturing. The primary function of this senior position is to lead efforts for the analytical development and method qualification for measuring tier, impurities, and product quality for in-process intermediates. This position will lead the strategy for measuring the attributes needed for successful process characterization and validation of the protein manufacturing processes. The successful candidate will also manage staff from scientists to research associates and provide scientific mentorship and technical guidance to members of the protein team.
- Provide strategic, tactical, and technical leadership in the development of analytical methods supporting protein manufacturing processes.
- Work with the protein development team to understand the manufacturing processes and determine the best methods to measure needed quality attributes.
- Provide strategy and technical leadership for developing the method qualification approach for assays used for process characterization.
- Provide technical direction, mentorship and coaching to the protein team on analytical approaches and technologies.
- Partner with CDMOs to transfer assays as needed to support process validation activities at CDMOs.
- Collaborate with the Vaxcyte AD/QC team to ensure alignment and best use of resources.
- Survey new analytical technologies and advise on most powerful analytical technologies.
- Work with lab automation to create high throughput methods leveraging liquid handling and robotic technologies.
- Author technical reports for regulatory submissions.
- Manage 1-3 direct reports.
- PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 8+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma / Biotech industry required.
- Outstanding collaboration skills and ability to work across disciplines.
- Must be a strong scientific leader who can guide scientists with clear goals of developing analytical methods, and critically and skillfully review and assess analytical methods under development. May need to provide direction for troubleshooting various issues during method development.
- Scientific creativity and curiosity with the ability to apply new technologies to complex analytical challenges.
- Proven track record of analytical development leadership for biologics.
- Extensive expertise in U/HPLC, CE, enzymatic assays, and impurity assays.
- Excellent technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
- Strong written and verbal communication skills, and efficient in communicating in inter-disciplinary and cross-functional teams.
- Experience managing direct reports and developing young scientists.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Associate Director, Downstream Development for Protein Development and Manufacturing
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $162,000 – $180,000
Send resumes to:
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.