Stability Manager

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 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 an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Manager/Sr. Manager of Stability within Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development. This position reports directly to the Director of Stability.
 
The position will be an integral part of the team implementing and maintaining cGMP Stability for all phases of clinical development. Primary responsibility will include managing stability studies for individual projects and stability data analysis. This individual will collaborate with QC members in a highly collaborative and cross-functional environment. The ideal candidate will apply strong stability experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.
Essential Functions:

• Manage and coordinate stability studies on development and clinical lots, summarize stability results to ensure scientific and technical excellence. Perform statistical analyses using statistical software’s such as JMP.
• This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
• Effectively disseminate stability data to various project team members, support the achievement of project milestones with regards to stability monitoring and derivation of expiration dates of clinical and in-process materials.
• The QC Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
• Drives and inspires team to foster an environment focused on continuous improvement activities for the clinical stability programs.
• Authors, reviews, revises, and approves SOP's, stability protocols and reports, specification documents (as required).
• Facilitates and executes stability study protocol strategy and design including calculation and execution of stability study set downs and pulls both independently and through direct collaboration with key cross-functional teams.
• Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
• Authors, reviews, and approves supporting memos and reports including those for expiry, interim/final stability reports and Annual Product Quality Reports.
• Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
• Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

Requirements:

• MS or BS with 5-10 years of industry experience in Pharma / Biotech industry required.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
• Strong understanding of various analytical chemistry methodology principles, and track record of validation for GMP release and stability testing, and stability trouble shooting.
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals is preferred.
• Experience in IND, NDA and BLA submission is highly preferred.
• Experience working in a regulated (GLP / GMP) environment.
• Attention to detail and excellent skills in record keeping / documentation.
• Extensive technical writing experience. 
• Project management skills including the ability to manage one’s project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management. 
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Ability to work globally with CMOs in different countries and continents.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Director of Stability
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $144,000 - $162,000