- Provide technical expertise in support of manufacturing deviations requiring lab-scale experimental assessment- Support analysis of samples generated in lab-scale studies (iCIEF, CE-SDS, SE-UPLC, ELISA, MFI, etc)- Drive implementation of automated laboratory processes utilizing Hamilton STAR, Hamilton Prep, and Tecan Fluent- Present key technical assessments to cross-functional teams including members of company leadership- Perform small-scale downstream purifications using AKTA Avant/Pure chromatography systems for process characterization and manufacturing process optimization efforts- Provide technical justification and supporting documentation to audiences including external partners and regulatory agencies (FDA) to justify process improvements- Author study protocols, design of experiments (DoE), lead small-scale laboratory study execution, analyze results (JMP statistical analysis), communicate results to leadership and make recommendations for process optimization- Proficiency in downstream laboratory techniques including small-scale column chromatography (Affinity, IEX, Hydrophobic Interaction, Size Exclusion) using AKTA Avant and Pure, protein filtration, viral inactivation- Act as subject matter expert or cross-functional team leader for manufacturing product quality investigations, CAPAs, and Change Controls

• Creates process evaluation reports, process transfer documentation and process characterization presentations.• Assists with training of new employees.• Provides input to production activities scheduling.• Coordinates regular equipment maintenance and calibrations.• Participates in continuous improvement initiatives to streamline production and day-to-day • Communicates with cross-functional teams to ensure organization of documentation and equipment used for bulk production.• Participated in equipment start-up, commissioning and validation activities.• Assist with troubleshooting in case of equipment failure.• Gathers, trends and analyzes process generated data.• Work to optimize, trend and report manufacturing process operational parameters during routine manufacturing campaigns.