Drug Product Analytics – Scientist/Senior Scientist

Location
Foster City, CA, United States
Posted
Jun 09, 2021
Ref
2020224407
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad- spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof- of-concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; 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. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds.

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 biologicals and vaccine Drug Products, especiall y adjuvant containing formulations. The responsibilities will be primarily to develop analytical methods and biophysic al 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. 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 biophysical characterization tools to support adjuvanted vaccine Drug Products  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  Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options Vaxcyte, Inc., 353 Hatch Drive, Foster City, CA 94404 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
- f industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >5 years of relevant experience
• The candidate will have had extensive experience in characterisation of vaccine Drug Product s containing proteins, polysaccharides and/or protein conjugates formulations preferably vaccine systems containing adjuvants
• Experience leading stability studies is required and the use of DoE for complex system optimisation 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, 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 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 (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: Associate Director of Formulation and Drug Product Development.

Location: Foster City, CA

Compensation:

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