Director/ Assoc. Director, Upstream Development for Protein Development & Manufacturing
Company: Vaxcyte, Inc.
Location: San Carlos
Posted on: August 7, 2022
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
- Lead the development of the upstream (cell-free) processes for
pipeline vaccine-based proteins (transferred from Research
- Mature the cell free protein synthesis process (including
complex cell-free reagents) into a commercial-ready manufacturing
- 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.
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
- Be an outstanding teammate and collaborate across groups both
internal and external to Vaxcyte.
- Represent upstream development at CMC meetings and with
- Cultivate a cohesive, innovative, nimble and productive team
- 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
- Phenomenal team skills; demonstrated ability to work
exceedingly well in a multi-disciplinary team structure.
- Experience bringing a protein (or protein-based)product to
- 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
- In-depth knowledge of protein synthesis biochemistry.
- Strong knowledge of E. coli molecular biology.
- Theoretical understanding of and experience with bioreactor
- Experience with cell-free upstream technology a plus but not
- 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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