Essential Functions:

• Lead a team of scientists to support the formulation development activities, including formulation screening, stability studies for thermal, freeze/thaw, shipping studies, agitation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
• Play a pivotal role in supporting investigations related to quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine drug product development, from early development to late-stage phases. These investigations will rely on the robust application of Design of Experiment (DoE) methodology and the utilization of a wide array of analytical techniques.
• Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
• Coordinate day-to-day laboratory activities and experiments of the Formulation Development Group, ensuring sufficient resource coverage and performance to meet scheduled turnaround times for formulation development deliverables. Identify of project scientific needs and gaps, including conceptual design, planning, execution through the team, data analysis and next-step proposal to both the DP and wider Project Team.
• Track stability data and provide regular updates on developmental and official stability studies to ensure timely communication of findings and necessary adjustments.
• Collaborate closely with DP management and external Vaxcyte Team members and to ensure supply/demand, in vivo, DS quality, analytical methods, CMO status and timelines are all in sync with formulation development activities to hit milestones as needed.
• Prepare protocols and write detailed reports on formulation development activities, data analysis, and outcomes, ensuring clear communication of results and recommendations.
• Work with external analytical and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods.
• This role requires people management, and the expectation will be to develop junior scientists scientifically, personally and professionally to advance both the program(s) and careers. 

Requirements:

• PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >6 years of relevant experience or a MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >10 years of industrial experience.
• The candidate should have had extensive experience in developing proteins, polysaccharides and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants (other non-vaccine biological experience also considered).
• Proficient in using biophysical and calorimetric techniques for proteins and protein-polysaccharide conjugates, including Circular Dichroism, Fourier Transform Infrared (FTIR) Spectroscopy, Fluorescence Spectroscopy, Differential Scanning Calorimetry (DSC), and Isothermal Titration Calorimetry (ITC).
• Experience in leading stability studies and investigating quality issues, deviations, out-of-specification results, along with using DoE for complex system optimization is required.
• Experience of manufacturing within GxP environments either directly or through CMOs
• Ability to move and multitask seamlessly between complex programs and project teams is required.
• Experience in management of junior scientists is strongly preferred, with a desire to continue in a managerial/leadership setting.
• Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
• The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn to effectively navigate 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/documentation.