EPM Scientific - Phaidon International
Principal Scientist - Downstream Process Development
EPM Scientific - Phaidon International, California, Missouri, United States, 65018
Principal Scientist - Downstream Process Development & ManufacturingGreater Los Angeles AreaCompetitive Compensation + excellent bonus/benefitsDuties and Responsibilities:Lead downstream process development (Late-Stage) and tech-transfer activities for Biologics Portfolio (mAb, ADCs & other protein-based therapeutics)SME for Purification Process Development on late stage - commercial manufacturingSet strategy for process scale-up, FMEAs, process robustness and characterization studies, process validation, continuous process improvements and regulatory filingsSupport R&D, commercial, manufacturing, quality assurance and business development departments
Qualifications:Experience collaborating across Sr. Leadership such as Analytical/QC, Drug Product, Manufacturing, Regulatory, Commercial OperationsPast experience overseeing outsourced vendors (CDMOs) and internal lab activitiesExperience leading process improvements for late-stage to commercial manufacturing DS activitiesM.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 7-10 years of industry experience
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Qualifications:Experience collaborating across Sr. Leadership such as Analytical/QC, Drug Product, Manufacturing, Regulatory, Commercial OperationsPast experience overseeing outsourced vendors (CDMOs) and internal lab activitiesExperience leading process improvements for late-stage to commercial manufacturing DS activitiesM.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 7-10 years of industry experience
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