Group Leader, Formulation Development Specialist

1 day ago


San Carlos, California, United States BioSpace, Inc. Full time
Job Title: Group Leader, Formulation Development

At Vaxcyte, we are seeking a highly skilled and experienced Group Leader, Formulation Development to join our team. 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.

Key Responsibilities:
  • Lead a team of scientists to support the formulation development activities, including formulation screening, stability studies, and container closure system evaluation.
  • 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.
  • 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.
  • Work with external analytical and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods.
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.
  • 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.
What We Offer:
  • A competitive compensation package, including comprehensive benefits and an equity component.
  • A dynamic and collaborative work environment with a team of experienced professionals.
  • Opportunities for professional growth and development in a rapidly evolving industry.
How to Apply:

Interested candidates should submit their application, including a cover letter and resume, to [insert contact information].



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