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

Location
Palo Alto, California
Posted
Oct 05, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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   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
    • All Vaxcyte employees require vaccination against COVID-19

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)

Reports to: Senior Director, Protein Development & Manufacturing

Location: Foster City, CA

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

Vaxcyte, Inc.
353 Hatch Drive
Foster City, CA 94404