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Online Resumes with "Antibody Drug Conjugates"
Accomplishments: * Actively consulting on, discovery and development of Antibody Drug Conjugates (ADCs) * Actively consulting on, small molecules process optimization, scale-up and regulatory aspects * Sepsis diagnostic kits (mAb based) business to Asia for development, manuf. and marketing. Consulting and Project Management * API Process Dev - (Malvern, PA) DP Formulations - Horizon Therapeutics (CA) * Duexis Tabs launched...
Tags for this Online Resume: Cancer, Adc (Advance Data Comm), Consulting, Outsourcing, Pharmaceutical, Management, API, Manufacturing, Application Program Interface, pharmaceutical, biotech, drug development, operations, regulatory
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA