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Full-Time

Group Leader

Formulation Development

Updated on 10/3/2024

Vaxcyte

Vaxcyte

201-500 employees

Develops vaccines for bacterial infections

Biotechnology
Healthcare

Compensation Overview

$150k - $174kAnnually

+ Equity Component

Senior, Expert

San Carlos, CA, USA

This position is onsite in San Carlos, CA.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Requirements
  • PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >6 years of relevant experience or a MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >10 years of industrial experience.
  • The candidate should have had extensive experience in developing proteins, polysaccharides and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants (other non-vaccine biological experience also considered).
  • Proficient in using biophysical and calorimetric techniques for proteins and protein-polysaccharide conjugates, including Circular Dichroism, Fourier Transform Infrared (FTIR) Spectroscopy, Fluorescence Spectroscopy, Differential Scanning Calorimetry (DSC), and Isothermal Titration Calorimetry (ITC).
  • Experience in leading stability studies and investigating quality issues, deviations, out-of-specification results, along with using DoE for complex system optimization is required.
  • Experience of manufacturing within GxP environments either directly or through CMOs
  • Ability to move and multitask seamlessly between complex programs and project teams is required.
  • Experience in management of junior scientists is strongly preferred, with a desire to continue in a managerial/leadership setting.
  • Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
  • The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn to effectively navigate multiple projects and timelines.
  • Strong interpersonal skills: ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team and well as across other teams.
  • Detail oriented, rigorous and excellent skills in record keeping/documentation.
Responsibilities
  • Lead a team of scientists to support the formulation development activities, including formulation screening, stability studies for thermal, freeze/thaw, shipping studies, agitation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
  • Play a pivotal role in supporting investigations related to quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine drug product development, from early development to late-stage phases. These investigations will rely on the robust application of Design of Experiment (DoE) methodology and the utilization of a wide array of analytical techniques.
  • Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
  • Coordinate day-to-day laboratory activities and experiments of the Formulation Development Group, ensuring sufficient resource coverage and performance to meet scheduled turnaround times for formulation development deliverables. Identify of project scientific needs and gaps, including conceptual design, planning, execution through the team, data analysis and next-step proposal to both the DP and wider Project Team.
  • Track stability data and provide regular updates on developmental and official stability studies to ensure timely communication of findings and necessary adjustments.
  • Collaborate closely with DP management and external Vaxcyte Team members and to ensure supply/demand, in vivo, DS quality, analytical methods, CMO status and timelines are all in sync with formulation development activities to hit milestones as needed.
  • Prepare protocols and write detailed reports on formulation development activities, data analysis, and outcomes, ensuring clear communication of results and recommendations.
  • Work with external analytical and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods.
  • This role requires people management, and the expectation will be to develop junior scientists scientifically, personally and professionally to advance both the program(s) and careers.

Vaxcyte develops vaccines aimed at preventing bacterial infections, focusing on diseases like invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Their lead product, VAX-24, is a pneumococcal conjugate vaccine that targets 24 strains of the Streptococcus pneumoniae bacteria and has received Breakthrough Therapy designation from the FDA. Vaxcyte utilizes advanced chemistry and a proprietary cell-free protein synthesis platform, XpressCF™, to create vaccines that can effectively address the complex defenses of bacteria while stimulating an immune response. This method sets them apart from traditional cell-based vaccine production. The company's goal is to develop and commercialize broad-spectrum vaccines to protect vulnerable populations from serious bacterial infections.

Company Stage

IPO

Total Funding

$2.3B

Headquarters

Foster City, California

Founded

2013

Growth & Insights
Headcount

6 month growth

31%

1 year growth

61%

2 year growth

125%
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Simplify's Take

What believers are saying

  • Significant investments from major financial entities like Vanguard and Mutual of America Capital Management indicate strong market confidence in Vaxcyte's potential.
  • The recent $816.5 million raised through stock and warrant sales provides substantial capital for advancing their vaccine pipeline.
  • The appointment of experienced board members like John Furey can provide strategic guidance and enhance corporate governance.

What critics are saying

  • The success of Vaxcyte heavily depends on the clinical and commercial success of its lead product, VAX-24, which is still subject to regulatory approval.
  • The competitive landscape in vaccine development is intense, with numerous established players potentially overshadowing Vaxcyte's market entry.

What makes Vaxcyte unique

  • Vaxcyte leverages its proprietary XpressCF™ cell-free protein synthesis platform, which allows for more efficient and versatile vaccine production compared to traditional cell-based methods.
  • Their focus on broad-spectrum vaccines, such as VAX-24 targeting 24 strains of Streptococcus pneumoniae, sets them apart in the vaccine development landscape.
  • The FDA Breakthrough Therapy designation for VAX-24 underscores the innovative potential and clinical significance of their lead product.