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Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

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...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

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

Well known winner!! If the job one chooses, regardless of the position, is NOT considered, THEIR, own business, never hire!

While in college in my early years, I was privileged to a guest lecture encounter with the actor Paul Newman. During a question and answer session the question arose, of what to do to land a job you might covet? His response was simply, “do or say something different than the next person”. The intimacy required to sell, not only products, but one's self, can only be achieved, if an individual has an incredible amoun...

Tags for this Online Resume: Inventory, Video, Electronics, Install, P&L, Sales, Sales Training, Training, Advertising, Automation, sales, inside sales, sales representative, account executive, technical sales, business development, District Management, radionics, District Manager, Regional Manager, Volume Sales