Ken Brandt
Director of Drug Product Development @Alto Ridge Advisory
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WORK HISTORY
Director of Drug Product Development @Alto Ridge Advisory
Led critical quality and operational projects for biotech and CDMO clients across North America. Provided end-to-end support in aseptic manufacturing, regulatory readiness, and CMC strategy- Directed drug product tech transfers for injectable biologics across EU and US sites- Prepared sterile operations teams for Pre-Approval Inspection (PAI) by FDA and EMA- Led risk-based validation and deviation/CAPA process overhaul- Mentored junior consultants in inspection strategy and quality leadership
EDUCATION
University of San Francisco
Bachelor of Science - BS
University of San Francisco School of Management
Master of Business Administration - MBA
SKILLS
ABOUT KEN BRANDT
I help life sciences organizations make systems work in practice. My background…
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