Associate Director, Raw Materials Validation Lead
San Carlos, CA, USA
Posted on Saturday, October 28, 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.
- Responsible for all deliverables of raw material method qualification/validation used in intermediates, DS and DP for various projects in the Vaxcyte pipeline.
- Contribute to and implement the high-level method qualification and validation strategy decided by CMC executive team. Accountable and responsible for implementing the detailed method qualification and validation strategy with the CMOs and CTLs.
- Collaborate with Analytical Development and interface with key stakeholders to determine when a method is suitable for method qualification/validation with a focus on raw materials. Review and evaluate method development data, reports and documents to be transferred to CMOs, provide technical and compliance feedback to internal and external stakeholders who have developed the analytical methods.
- Collaborate with CDMOs to design an effective method qualification / validation plan, and lead method qualification /validation activities to ensure campaign readiness.
- Review and approve raw material test methods, method qualification / validation protocols and reports, may need to author method qualification / validation protocols and reports. Responsible for the accuracy and compliance of these documents.
- Accountable for execution of method implementation, validation, and transfer and responsible for 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 quality event management (deviations, investigations, change control) related to method qualification / validation.
- Manage outsourced GMP testing at CDMOs.
- Support audit, inspections, and health authority responses.
- Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
- PhD in Chemistry, Analytical Chemistry, or related field with 7+ years relevant industry experience; MS or BS with 12+ 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 focused on raw materials and successful track record of method transfer, trouble shooting and validation for GMP release testing.
- Have solid understanding of various analytical technology used for analysis of raw materials including small molecules, DNAs, proteins, and other large molecules. Able to apply the knowledge and gain in depth understanding of variety of methods placed for raw materials used in 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 raw materials, small molecules, biologics and vaccines, and expiry dating.
- Demonstrated ability of applying regulatory guidance to formulate practical solutions and phase appropriate analytical transfer, and validation strategy, with a focus on raw materials.
- 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: Senior Director, ASAT for Quality Control
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $182,000 – $188,000
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.