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Online Resumes with "Clinical Manufacture"
Clinical Quality Assurance
SUMMARY * 20+ years of experience in Quality Management and continuous improvement of quality, within Drug Safety, Clinical, Manufacturing, Regulatory Compliance and R &D domains of Bio-Pharmaceuticals * Conducted risk based Investigator site global audits including contract global central clinical labs * Conducted and Managed CRO's, 3rd party vendors / service providers for GCP and GvP compliance * Supported Internal and e...
Tags for this Online Resume: Services, Compliance, Infrastructure, Link Access Procedure (LAP), Research and Development, SDLC, Test, Packaging, Product Development, Quality
Pharmaceutical Sales Representative - 19 Years of Experience - Near 01746
Summary Highly motivated, dedicated and results oriented sales and marketing professional with over eighteen years experience in Contract drug development and manufacturing, Engineered process equipment and Separations Technologies. Global thinker with strong business development experience. Dynamic self- starter with outstanding leadership and communication skills collaborating with multicultural, cross- functional teams t...
Tags for this Online Resume: Sales, Sales Engineer, Business Plan, Engineering, High Performance Liquid Chromatography (HPLC), Process Engineering, Heat Exchangers, HVAC, Mining, Pharmaceutical Industry, ACCOUNT DIRECTOR, DRUG DEVELOPMENT
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