Associcate Scientist II (Contract), Drug Product Analytics

Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, especially immunoassays and multiplexed immunoassay formats. 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 lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping.

• Execute routine studies to support internal release, development, and stability samples using a variety of analytical techniques, particularly multiplexed immunoassays (such as MSD) across Drug Product working groups, ensuring high-quality data generation and reporting.
• Execute non-GxP stability study analysis for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance and adjuvanted vaccine Drug Product materials. 
• Execute and contribute to the development of workflows on automation systems, such as Hamilton, Tecon, Integra.
• Design and execute periodic testing of critical assay reagents, such as antibodies, QC samples, calibrators amongst others.
• Analyze and interpret complex assay data, identify trends or deviations, and communicate findings to project teams to support development decisions
• Support the Vaxcyte PCV and VAXA1 products, external analytical, and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods. 
• Vaxcyte is looking for a 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 is predominantly lab-based, requiring excellent scientific judgement, independence, rigor, and thorough record-keeping.

• BSc or MSc in Biochemistry, Molecular Biology, Immunology or related field preferred, with minimum 2-4 years of experience in the pharmaceutical and/or biotechnology industries. 
• Hands-on experience developing, optimizing, and executing single-plex and multiplex immunoassays (MSD, Luminex, Multi-arrays) with demonstrated ability to troubleshoot assay performance and interpret assay data.
• Hands-on experience with executing workflows on automated liquid handling platforms.
• Experience analyzing and visualizing bioassay data using software tools such as Excel, Prism, JMP, or equivalent statistical/data analysis platforms
• The candidate will preferably have established practical experience in the analytical characterization of large biomolecular Drug Products in pre-filled syringes and vials.
• Experience with other bioanalytical assays and plate-based assays pertinent to product release testing and long-term stability studies will be considered an advantage.
• Experience in authoring analytical technical documents, including method protocols, SOPs, and reports, as well as experience recording and templating electronic laboratory notebooks (eLN).
• The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn, to effectively navigate 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, as well as train other analysts and team members.
• Detail-oriented, rigorous, and excellent skills in record keeping.