Sr. Quality Control Manager, Method Validation and Transfer

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.
Essential Functions:

• Collaborate with Analytical Development and interface with key stake-holders to determine when a method is suitable for method qualification/validation.
• Contribute to and implement the high level method qualification and validation strategy decided by CMC executive team.
• Collaborate with CMOs and CTLs to design an effective method qualification/validation plan, and lead method qualification/validation activities to ensure campaign readiness.
• Review and approve method qualification and validation protocols and reports, may need to author method qualification/validation protocols and reports.
• Evaluate analytical method readiness for transfer, provide technical and compliance feedback to internal and external stakeholders who have developed the analytical methods.
• Collaborate with Analytical Develop Scientists, Formulation, Process Development, Conjugation to gain the necessary method and product knowledge.
• view analytical method development data, reports and method document to be transferred to CMOs.
• Responsible for quality event management (deviations, investigations, change control) related to method qualification/validation.
• Provide technical and strategic functional oversight, including resource management for method validation and transfer.
• Accountable for execution of method validation and transfer and supportive processes including sample planning, scheduling, documentation, compliance / technical review and scientific interpretation of data to ensure the successful validation/qualification/transfer of methods.
• Responsible for method qualification/validation for raw materials, intermediates, DS and DP for various projects in the Vaxcyte pipeline.
• Manage outsourced Qualification/Validation of methods at CMOs or CTLs.
• upport audits, inspections and health authority responses.
• 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. 

Requirements:

• MS or BS with 7-10 years of industry experience in Pharma / Biotech industry required.
• Demonstrate sound complex decision making skills and exhibit good judgment. Make decision with understanding of the strategic context and short and long term impact of decisions on other departments or functional areas before making them; able to decide and act effectively without having the whole picture;
• Understanding of various analytical chemistry methodology principles and successful track record of method transfer, trouble shooting and validation for GMP release and stability testing. 
• Have solid understanding of various analytical technology used for analysis of proteins, conjugates, small molecules, and other large molecules. Able to apply the knowledge and understand gain in depth understanding of variety of methods placed for Vaxcyte vaccine programs.
• Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards;
• 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.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Expert analytical skills for integrating and interpreting interdisciplinary project information; thorough understanding of the drug/vaccine development process.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to analytical method qualification/validation for small molecules, biologics and vaccines, stability study design and expiry dating.
• Demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical transfer, validation and stability strategy.
• Ability to work globally with CMOs in different countries and continents.
• Self-starter and resourceful problem solver, able to move up learning curve independently and map out intermediate milestones to achieve project goals.
• Experience in IND, NDA and BLA submission is highly preferred.
• Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• All Vaxcyte employees require vaccination against COVID-19. 

Reports to: Associate Director, Method Transfer and Quality Control
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.