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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

Science, Edcucation, & Sales

Although I have enjoyed the past seventeen years working with high school students, I am ready to make a change in my career path. I would like to put my knowledge and interest of Biology to use in a business setting. I work hard, set goals for myself, and I am willing to take on new challenges. In addition, I feel comfortable meeting new people and enjoy working with other professionals.

Ideal Companies: Syneos Health, Covance, University, Eli Lilly, Amylin Biopharmaceuticals, Education, Edmentum

Tags for this Online Resume: Management, Chemistry, Microbiology, Science, Integrate, Microsoft, Microsoft Office, Scheduling, Assessments, Sales, Powerschool, Google Suite, Naviance