Director/ Associate Director, Analytical Development for Characterization

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 a highly skilled, motivated and creative leader to join Vaxcyte’s Vaccine Product Development organization as an Associate Director/Director within Analytical Development and QC department. The primary function of this Director level position is to lead the analytical characterization for all products in preclinical and clinical phases. This position reports directly to the Senior Director of Analytical Development and QC (AD & QC). The successful candidate will also manage and grow a group of staff from staff scientists to research associates, and provide scientific mentorship and technical guidance to members of AD & QC department. 
Essential Functions:

• Provide strategic, tactical and technical leadership in the development of analytical methods for the purpose of characterizing drug product, drug substance, intermediates and critical raw material.
• Take on end-to-end responsibility of method development for characterization of proteins, bacterial polysaccharides, polysaccharide-protein conjugates, and adjuvanted vaccines product. Responsibility also includes resource planning, team productivity and timeline management of the deliverables.
• Drive analytical innovation and stay on top of cutting edge analytical technology.
• Introduce and establish novel technology in house if necessary.
• Provide technical direction, mentorship and coaching to the analytical characterization team.
• Manage performance and development of personnel to ensure achievement of organizational and department goals.
• Cultivate a cohesive, innovative, nimble and productive team environment.
• Ensure characterization methods developed internally or through CROs are technically solid, robust and provide in-depth understanding of process and product that supports regulatory filing.
• Provide investigation tools and conduct studies for troubleshooting of QC testing or method related issue.
• Collaborate with Formulations and Process Development to provide analytical solutions for process understanding, troubleshooting and characterization.
• Author technical reports, multiple regulatory submission and address health authority questions for IND and BLA approval.
• Evaluate and establish contracts with CDMO/CROs for characterization method development, testing or stability studies.

Requirements:

• PhD in Chemistry, Analytical Chemistry, Organic or Biochemistry, with 10+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma / Biotech industry required.
• Ideal candidate will have proven track record of heading analytical development function for biologics, carbohydrate and conjugates.
• Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biological drug development; experience with other large molecule modalities such as ADC or vaccines is a plus.
• Extensive expertise in mass spectrometry, U/HPLC, and other analytical technologies as applied to the analysis of protein and conjugate drug products.
• Strong understanding of various analytical chemistry methodology principles and successful track record of method development, trouble shooting and validation for GMP release and stability testing.
• Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Strong written and verbal communication skills, and efficient in communicating in interdisciplinary and cross-functional teams.
• Experience developing protein and conjugate assay methodologies such as proteomics, peptide mapping by MS, H/UPLC, capillary electrophoresis, SEC, CEX, icIEF and/or oligosaccharide analyses is a plus.
• Understanding of FDA, EMA and other regulatory agency guidance associated with release and characterization assays.
• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
• All Vaxcyte employees require vaccination against COVID-19. 

Reports to: VP, Analytical Development & Quality Control

Location: San Carlos, CA

Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.


Vaxcyte, Inc.
825 Industrial Rd.
Suite 300, San Carlos, CA 94070