Principal Scientist - Downstream Process Development & Manufacturing
Greater Los Angeles Area
Competitive Compensation + excellent bonus/benefits
Duties 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 manufacturing
- Set strategy for process scale-up, FMEAs, process robustness and characterization studies, process validation, continuous process improvements and regulatory filings
- Support 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 Operations
- Past experience overseeing outsourced vendors (CDMOs) and internal lab activities
- Experience leading process improvements for late-stage to commercial manufacturing DS activities
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 7-10 years of industry experience
