Scientist I, Formulation Development - San Carlos California

Company: Vaxcyte Inc.
Location: San Carlos, California
Posted On: 11/19/2024

Join our Mission to Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.Summary:Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team. The candidate will have extensive knowledge and practical experience in formulation development of vaccines, preferably adjuvant containing formulations, complemented with a broad range of vaccines analytical techniques and in particularly in-depth experience in biophysical characterization of formulations. The candidate will have a strong industry-based experience in bringing a product from early to late-stage development, including process scale-up and manufacturing. Having worked with external analytical and manufacturing CMOs would be beneficial as well as a good understanding of GxP testing and manufacturing guidelines.This position is for a scientific role which will be mostly lab based, which will require excellent scientific judgement, independence, rigor and thorough record keeping. The primary responsibility for the incumbent will be to facilitate formulation development activities of Vaxcyte's lead product candidate post Ph1/2, through Phase 3 and culminating in BLA filing and commercial manufactures.Essential Functions:
  • Progressing formulation development activities, including stability studies for thermal, freeze/thaw, photostability and agitation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
  • Performing formulation screening studies to support the selection of buffering conditions, stabilizers, and surfactants in vaccine formulations.
  • Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
  • Supporting the manufacturing of formulations and critical reagents to facilitate tech transfer and the implementation of processes and analytical methods at CROs.Requirements:
    • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with > 4 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with > 2 years of relevant experience.
    • Experience of manufacturing within GxP environments either directly or through CMOs.
    • The candidate will have had extensive experience in developing proteins, polysaccharides and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants (other biological experience also considered).
    • Experience leading stability studies is required and the use of DoE for complex system optimization would be beneficial.
    • Experience in spectroscopic methodologies, particle light scattering analysis, quantitative subvisible particle analysis, visual inspection, is needed.
    • Strong scientific skills are 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 Vaxcyte's 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 as well as across other teams.
    • Detail oriented, rigorous and excellent skills in record keeping/documentation.Reports to: Director, Formulation DevelopmentLocation: San Carlos, CACompensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $125000 - $133,000Send resumes to: Vaxcyte, Inc.825 Industrial Road, Suite 300San Carlos, CA 94070We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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