Scientist II, Drug Product Analytics
Product, Data Science
San Carlos, CA, USA
Posted on Tuesday, April 11, 2023
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 www.vaxcyte.com.
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. 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-XP, 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.
Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have extensive knowledge and practical experience in analyzing and characterizing Biological molecules (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.
In addition, 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 lab based, whilst requiring excellent scientific judgement, independence, rigor and thorough record keeping.
- Develop analytical methods, biophysical characterization assays and manage routine testing in support of formulation and process development across all projects in the pipeline in all stages of development.
- Work independently/under minimal supervision to develop analytical methods, perform analytical data review, authorship of protocols and reports, and support activities during assay transfer with the Vaxcyte QC team and external CMO partner groups.
- 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.
- 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.
- The candidate will have had 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 preferred. 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.
- 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 in order to effectively navigates 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
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $145,000 - $160,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
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