Meet's innovative and fast-growing client in the SF Bay Area has engaged us on an exciting new search for a talented Group Leader Formulation Development!
You'll act as the DP subject matter expert and be responsible for supporting formulation drug product development activities by overseeing and executing investigations while developing and deploying strategies aimed to resolving a range of drug product-related challenges. You will have the opportunity to join a growing biotech organization with a robust pipeline of vaccines to combat infectious diseases across the globe. They are well-funded and offer comprehensive benefits.
Essential Functions:
- Lead a team of scientists in formulation development, overseeing screening, stability studies (thermal, freeze/thaw, shipping, agitation), and container closure evaluation for Drug Substance (DS) and Drug Product (DP).
- Support investigations of quality issues, deviations, and anomalies across all stages of vaccine development using Design of Experiment (DoE) and analytical techniques.
- Apply biophysical methods to understand antigen/adjuvant interactions and optimize formulations.
- Coordinate daily lab activities, ensuring resources meet deadlines, and address project needs from design to execution and data analysis.
- Track stability data, providing updates to ensure timely communication and adjustments. Collaborate with internal and external teams to align supply/demand, DS quality, and timelines with formulation milestones.
- Prepare protocols, reports, and ensure smooth tech transfer with CMOs.
- Manage and develop junior scientists, supporting both program goals and career growth.
Requirements:
- PhD in Pharmaceutics, Chemistry, Biophysics, or Biochemistry with 6+ years of relevant experience, or MSc with 10+ years of industrial experience.
- Experience with Aluminum Adjuvant, highly preferred.
- Extensive background in developing formulations for proteins, polysaccharides, or protein conjugates, ideally for vaccine systems with adjuvants.
- Proficient in biophysical and calorimetric techniques (e.g., Circular Dichroism, FTIR, Fluorescence Spectroscopy, DSC, ITC).
- Experienced in leading stability studies, resolving quality issues, and using DoE for system optimization.
- Familiar with GxP manufacturing, including CMO collaboration.
- Strong leadership, multitasking, and project management skills, with experience managing junior scientists.
If you're interested in hearing more about this opportunity please apply or reach out to ...@peoplewithchemistry.com