Staff Scientist Drug Product Formulation

Meet’s innovative and fast-growing client in the SF Bay Area has engaged us on an exciting new search for a talented Staff Scientist Drug Product Formulation!

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:

Leading and conducting 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.

Use of Design of Experiment (DoE) methodology and the utilization of a wide array of analytical techniques.

Analyze, interpret, and report on investigation findings, identifying root causes and proposing corrective and preventive actions.

Support formulation development activities, including stability studies for thermal, freeze/thaw, and agitation, kinetic analysis of antigen degradation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.

Requirements:

A Ph.D. or Master's degree in a relevant scientific field.

At least 3-5 years of experience in vaccine drug product development and product investigation, with a focus on adjuvanted vaccine drug products.

Extensive experience in the use of statistical analysis and Design of Experiments (DoE) for complex system optimization.

Strong experience with analytical techniques such as MSD, ELISA, Laser diffraction, liquid chromatography and adjuvant antigen binding characterization.

Experience with biophysical and calorimetric methodologies applied to proteins and protein polysaccharide conjugates such as Circular Dichroism, Fourier Transformed Infrared (FTIR) Spectroscopy, Fluorescence Spectroscopy, Differential Scanning Calorimetry (DSC) and Isothermal titration calorimetry (ITC).

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