Scientist/ Sr. Scientist, Drug Product Analytics

Company Profile:

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 100 employees and anticipates continued, significant growth. On January 6, 2022, Vaxcyte announced that the U.S. Food and Drug Administration (FDA) had cleared the Investigational New Drug (IND) application for VAX-24, its lead vaccine candidate. The Company initiated the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and expects to announce Phase 2 topline immunogenicity, safety, and tolerability results by the end of the year. VAX-24 was designed to prevent 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.
 
Summary:

Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development 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 be responsible for maintaining lab operations and will require managing a team of 3-4 junior 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 >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 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 Formulation and 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 of Drug Product Analytics.

Location: San Carlos, CA

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