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Director/ Assoc. Director, Upstream Development for Protein Development & Manufacturing

Company: Vaxcyte, Inc.
Location: San Carlos
Posted on: August 7, 2022

Job Description:

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 . 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.Summary:Vaxcyte is looking for an energetic and talented individual to join Vaxcyte s Vaccine Product Development organization as an Associate Director/Director of upstream development and manufacturing within the Protein Development and Manufacturing group. --- A dynamic leader that can cultivate a team and develop employees while driving progress on the pipeline.--- An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to achieve company goals.--- A scientific thought leader capable of synthesizing complex biochemistry into well-designed experiments capable of illuminating the unknown; able to plan and utilize team strengths to execute.--- The ability to analyze and concatenate data to draw conclusions, make clear decisions, and communicate salient points concisely.--- A strong sense of ownership and accountability; commitment to Vaxcyte s mission.Essential Functions:

  • Lead the development of the upstream (cell-free) processes for pipeline vaccine-based proteins (transferred from Research team).
  • Mature the cell free protein synthesis process (including complex cell-free reagents) into a commercial-ready manufacturing technology.
  • In coordination with CMO, devise and oversee late-stage process characterization and process validation strategies for the cell-free process consistent with CMC-regulatory guidance.
  • EnsureallCMOoversightresponsibilitiesforproteinsarecarriedoutinamannercompliantwith internal Vaxcyte SOPs and cGMP requirements.
  • Manage a group of two (with potential to grow) and collaborate effectively with the downstream groups within protein development and manufacturing.
  • Be an outstanding teammate and collaborate across groups both internal and external to Vaxcyte.
  • Represent upstream development at CMC meetings and with external partners.
  • Cultivate a cohesive, innovative, nimble and productive team environment.Requirements:
    • PhD in Chemical Engineering or Chemistry/Biochemistry with 10+ years of relevant Pharma/Biotech industry experience, or MSin Chemical Engineering or Chemistry/ Biochemistry with 15+ years of relevant Pharma/Biotech industry experience.
    • Proven leadership skills.
    • Outstanding organization and planning skills.
    • Clear and compelling(written and oral) communication skills.
    • Phenomenal team skills; demonstrated ability to work exceedingly well in a multi-disciplinary team structure.
    • Experience bringing a protein (or protein-based)product to market.
    • Experience partnering with CMOs.
    • Experience authoring IND and BLA Module 3 sections.
    • GMP knowledge and experience, preferably as it applies to both manufacturing and QC.
    • Exceptionally strong from a technical/ scientific perspective.
    • In-depth knowledge of protein synthesis biochemistry.
    • Strong knowledge of E. coli molecular biology.
    • Theoretical understanding of and experience with bioreactor scale up.
    • Experience with cell-free upstream technology a plus but not required.
    • Experienced with Design of Experiments(DoE).
    • All Vaxcyte employees require vaccination against COVID-19.Reports to: Senior Director, Protein Development & ManufacturingLocation: San Carlos, CACompensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Keywords: Vaxcyte, Inc., San Francisco , Director/ Assoc. Director, Upstream Development for Protein Development & Manufacturing, Executive , San Carlos, California

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