Senior Formulation Development Scientist
2 weeks ago
Vaxcyte is seeking a highly skilled and experienced Formulation Development Scientist to join our team in San Carlos, CA. As a key member of our Formulation and Drug Product Development team, you will be responsible for leading the formulation development activities across all our programs, including formulation screening, stability studies, and container closure system evaluation.
The ideal candidate will have a strong background in biophysics and formulation development, with experience in developing proteins, polysaccharides, and/or protein conjugates formulations for vaccines. You will be responsible for applying biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
This is a scientific and leadership role that requires excellent scientific judgment, independence, rigor, and thorough record keeping. You will be expected to work closely with the project, analytical, DS, and DP team members to move all programs through the development phase into phase 1, 2, 3 clinical trials and into preparations for commercial launch.
Key Responsibilities- Lead a team of scientists to support the formulation development activities, including formulation screening, stability studies, and container closure system evaluation.
- 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 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 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.
- 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.
- Extensive experience in developing proteins, polysaccharides, and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants.
- 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.
Vaxcyte offers a competitive compensation package, including comprehensive benefits and an equity component. The salary range for this position is $150,000 - $174,000.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced Formulation Development Scientist looking for a new challenge, please submit your application.
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