Career | <?phpecho $jobTitle;?> | <?phpecho $companyName;?>

Sr. Scientist, Drug Product Analytics

Vaxcyte

San Carlos, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Industry: Vaccine
  • Post Date: 09/23/2024
  • Website: www.vaxcyte.com
  • Company Address: 825 Industrial Rd, Suite 300, San Carlos, California 94070, US

About Vaxcyte

Vaxcyte 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

Job Description

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, carrier-sparing pneumococcal conjugate vaccine (PCV) 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-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. 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 www.vaxcyte.com.
 
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of 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-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
 
Summary:
 
Vaxcyte is looking for an energetic and talented individual to join our Drug Product Analytics team. The candidate must have extensive knowledge and practical experience in analyzing and characterizing Biological Drug Products (proteins, polysaccharide conjugates, vaccines) using HPLC, CE, spectrophotometric techniques, light scattering and particle sizing techniques. Experience in analyzing vaccine and adjuvant containing formulations is a plus.
 
The responsibilities will be primarily to develop analytical methods, biophysical characterization assays and coordinate routine testing in support of formulation development across all projects in the pipeline in all stages of development. The position will require managing a team of 3-4 scientists.
 
The candidate will work independently to develop analytical methods, perform analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer with the Vaxcyte QC team and external CMO partner groups.
 
This will consist of:
· Leading analytical method development and execution for Drug Product characterization including direct management of junior scientists.
· Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
· Support formulation selection and stability analysis of Intermediate and Drug Substance materials.
· Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
 
Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a scientific role which will be partly lab based, whilst requiring excellent scientific judgement, independence, rigor and thorough record keeping.

Requirements:

    • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >10 - >7 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >3 years of relevant experience.
    • The candidate will have had strong experience in characterization of Biological Drug Products containing proteins, polysaccharides and/or protein conjugate formulations. Experience in characterization of   vaccine systems containing adjuvants will be an advantage.
    • Experience of testing within GxP environments either directly or through CMOs.
    • Strong experience in method development for HPLC (SEC, RP) based assays, particle light scattering analysis (DLS, MALS), quantitative subvisible particle analysis, visible analysis, is required. Experience in plate-based assays (ELISA, immunoassays, MSD) is a plus.
    • Demonstrated experience in authoring analytical technical documents, including method protocols and SOPs, assay transfer and implementation protocols and reports, validation protocols and reports.
    • Participated in method transfers to external vendors and to internal collaborators.
    • Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
    • Managerial experience is of notable benefit.
    • 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 are necessary to collaborate effectively with the rest of the Drug Product Development team and well as across other teams.
    • Detail oriented, rigorous and excellent skills in record keeping.
    • All Vaxcyte employees require vaccination against COVID-19.
Reports to: Associate Director, Drug Product Analytics
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $152,000 – $170,000
 
 
Send resumes to:
 
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
 
We 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.