Drug Product Analytics - Scientist/Senior Scientist

Location
Foster City, California, United States
Posted
Jul 25, 2021
Ref
1854094750
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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, especially adjuvant containing formulations. 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.

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 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 >5 years of relevant experience

• The candidate will have had extensive experience in characterization of vaccine Drug Products 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 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, 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