Rachel Erwin Email and Phone Number

Characterized, optimized, and scaled up purification unit operations for 8+ programs from a 2 L to a 10,000 L bioreactor scale. Supported the technology transfer and cGMP manufacturing with routine onsite support.Performed chromatographic, filtration, and membrane unit operations (polishing chromatography affinity capture chromatography, virus-retentive filtration, depth filtration, ultrafiltration/diafiltration, etc) at bench and pilot scales.Leveraged principles of Quality by Design for commercially-enabling process development, with a focus on polishing chromatography unit operations. Performed risk assessments to identify key factors and responses for custom design of experiments (DOE). Analyzed and interpreted results through statistical multivariate linear regression and Monte Carlo simulations while taking into account process setpoints, ranges, and normal sources of variability.Authored and reviewed technical documentation including development reports, process transmittals, manufacturing records, and relevant sections of biologics license applications (BLA).

Work closely with a Principle Scientist to:•Design experiments and conduct laboratory procedures to give relevant and useful information regarding upcoming packaging materials•Assess the behavior of protein drugs in specific packagingWork with the Research & Development Engineering Team to:•Characterize, using Instron technology, the force profile of a plunger in a cartridge system used in parenteral devices •Compare the performance of these cartridges filled with either high or low viscosity fluid•Use Minitab to run statistics on the acquired data