Senior Scientist/Team Leader - Drug Product Analytics

Company Profile
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. 

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 analyzing and characterizing large biomolecules and biological Drug Products. The responsibilities will be primarily to develop analytical methods and biophysical characterization assays, perform routine testing in support of formulation development and work with CRO/CMO for Drug Product analytical method tech transfer. This position is to support the formulation team across all projects in the pipeline in all stages of development. In addition, Vaxcyte has relocated to San Carlos in late 2021, into custom designed, state of the art laboratories and working environment.

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

Essential Functions

• • Leading:

• Analytical method development ready for transfer to the CRO
• Routine analysis of internal stability samples and reporting of data
• In depth characterization of the Drug Product 
• This role will manage ~3-5 junior scientists
• Evaluate and develop the most appropriate biophysical characterization tools to support adjuvanted vaccine Drug Products 
• Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options
• Leading non GxP stability studies for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance and Drug Product materials. 
• Work with Vaxcyte QC team, external analytical and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods 
• All Vaxcyte employees require vaccination against COVID-19. 


• 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 leadership role, 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 with >5 years of relevant experience 
• The candidate will have had extensive experience in characterization of large biomolecule Drug Products, preferably vaccine systems containing adjuvants 
• Experience leading stability studies is required and the use of DoE for analytical method optimization would be beneficial 
• Experience of testing within GxP environments either directly or through CMOs 
• Strong experience in spectrometric methodologies, plate-based assays, immunoassay/ELISA, HPLC/UV and SEC/MALS, particle light scattering analysis, quantitative subvisible particle analysis, and visible analysis, is required 
• 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 required 
• 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 (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

Reports to: Director of Formulation & Drug Product Development

Location: San Carlos, CA

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

Vaxcyte, Inc.
825 Industrial Rd.
Suite 300, San Carlos, CA 94070