Director, Analytical Development

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-31, 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 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. 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-XP, 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 a highly skilled, motivated and creative leader to join Vaxcyte’s Vaccine Product Development organization as a Director within Analytical Development and QC department. The primary function of this Director level position is to lead efforts for the analytical development and characterization for early clinical phase products. This position reports to an Executive Director within Analytical Development and QC (AD&QC). The successful candidate may also manage staff from staff scientists to research associates, and provide scientific mentorship and technical guidance to members of ADQC department. 
Essential Functions:

• Provide strategic, tactical, and technical leadership in the development of analytical methods for early phase pre-clinical and clinical products with emphasis on HPLC and MS techniques for proteins.
• Work with contract manufacturing/research organizations and outside testing facilities to development and implement analytical testing for early-stage products.
• Provide strategy and technical leadership for developing the analytical control system for early-stage products, provide clear rationale and supporting data to gain the CMC team endorsement of the decision.
• Provide technical direction, mentorship and coaching to the analytical development team.
• Ensure methods developed internally or through CROs are technically solid, suitable for their intended purpose, robust, and provide in-depth understanding of process and product that supports regulatory filing.
• Provide technical support to Vaxcyte QC team to ensure smooth transfer of methods to the GMP test sites, as well as ensure the method qualification and validation protocols are adequately designed with acceptance criteria supported by development and QC test data.
• Provide investigation tools and conduct studies for troubleshooting of QC testing, method qualification/validation or method related issue.
• Collaborate with Formulations and Process Development to provide analytical solutions for process understanding, troubleshooting and characterization.
• Author technical reports for regulatory submissions.
• Evaluate and establish contracts with CDMO/CROs for method development and testing.

Requirements:

• 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.
• Proven leadership skills.
• Outstanding organization and planning skills.
• 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.
• Proven track record of analytical development leadership for biologics and small molecules, experience with vaccines, carbohydrate, or conjugates is a plus. 
• Extensive expertise in U/HPLC, CE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing. 
• Excellent 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 inter-disciplinary and cross-functional teams.
• Understanding of FDA, EMA and other regulatory agency guidance associated with release and characterization assays is a plus.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Vice President, Analytical Development & Quality Control
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $212,000 - $225,000