Associate Scientist/Scientist of Drug Product Engineering

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Job description

Company Profile

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.

Summary

Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development (DP) team. The primary responsibilities for the incumbent will be to support the DP process development of pre-clinical programs through to the phase 3 and commercial readiness of the lead program. This position will require the candidate to develop scalable and scaled manufacturing process for Vaxcyte's vaccine portfolio, being highly complex biological products.

Due to the high number Drug Substances (24) within the DP and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. The candidate will need to relish the scope and size of this unique challenge. In addition, Vaxcyte has relocated to San Carlos in late 2021, into custom designed, state of the art laboratories and working environment.
Essential Function

• Generate early stage DP manufacturing processes that allow for accurate multivalent Drug Substance (DS) mixing, aseptic handling and homogeneity of the final suspension mixture prior to fill.
• Enable the team in general process design, including contact material selection, hardware design/construction, filter selection/sizing, mixing and filling activities at the phase 1 scale and in down scaled models
• Play a significant role in the build out of an in-house near full-scale production lab for development and trouble shooting of the phase 3 process
• Aid in oversight of the fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables
• In concert with the CMC team and external guidance, aid in late-stage process characterization and process validation
• Provide engineering support, in conjunction with the CMO to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of the 24 DSs
• Work with the DP Formulation Team to troubleshoot and optimize the Drug Product as required for phase 1, phase 3 and commercial needs
• Scaleup and validation of mixing solutions for the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill and facilitation of internal development work.
• All Vaxcyte employees require vaccination against COVID-19

Requirements

• BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >2 year of industrial experience.
• Experience in early and/or late-stage clinical manufacturing within fill finish sites under GMP regulations
• Experience of chemical engineering in the biological manufacturing space
• Experience in the development of scaleup/down models for DS or DP processes
• Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats
• Ability to work within in a fast-paced, cross functional environment, multitasking as needed

Reports to: Team Lead of Drug Product Engineering

Location: San Carlos, CA

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