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Online Resumes with "cmc"
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices
Experienced Hands-on Technology Manager with proven transformational, Technology Operations, Global Project Delivery Manager. Well versed in creating and implementing vision and strategy. Cloud Operations, Product development, SaaS Operations, Establishin
Interested in Datacenter, Cloud and IT Manager and above roles.
Ideal Companies: SMB to Large companies in and around Silicon Valley Bay area.
Tags for this Online Resume: Information Technology, Linux, Hierarchical Storage Management, HSM, Licensing, MySQL Database, Oracle, PHP Programming Language, Apache Web Server, CT
Clinical Quality Assurance - 18 Years of Experience
Pharmaceutical technical regulatory submission manager, CMC * Well versed in CTD submission structure and content for both biologics and small molecules for development and marketed products * Fifteen years substantive and technical editing experience with a practical sense for scientific communication * Experience with pharmaceutical production operations, global supply chain networks, inventory planning, and production m...
Tags for this Online Resume: Reporting Tools, Management, Merchandising, Product Development, Scheduler, Sourcing, Inventory, Retail, Capacity Planning, Documentation
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
Developer
Tags for this Online Resume: Active Server Pages, Coding, Distribution, Microsoft ASP.Net, Oracle PL/SQL Programming language, Performance Tuning, Structured Query Language, Test, Triggers, AutoSys
Clinical Quality Assurance - 0 Years of Experience
Executive Profile Summary I have for over 25 years acquired a vast knowledge in cGMP, Quality Management Systems, and Quality & Compliance in the areas of Pharmaceutical / Biotechnology / Biologics / Chemical Product Development / Quality Assurance & Control, and Food and Chemical Industries (which includes Food & Consumer Goods), (Industrial Retail & General Manufacturing ). My detail-oriented critical thinking creative-pr...
Tags for this Online Resume: Quality, Quality Assurance, Management, Test, Consulting, Engineering, Pharmaceutical, Protocol, QA/QC, Acquired Immune Deficiency Syndrome (AIDS)
Director
Tags for this Online Resume: Voice, Management, Advertising, Cellular, Consulting, Ethernet, Hub, Lan/Wan, Local Area Network, Marketing Management
Database Administrator - 20 Years of Experience - Near 27527
Tags for this Online Resume: Cobol II, Cobol Programming Language, Database, Database Maintenance, System design, Adaptec Lantastic, Computer Associates Telon, IBM DB2 Database, Micro Focus, Microfocus
Delivery Services Truck Driver - 0 Years of Experience
Tags for this Online Resume: Novell Netware, Crane Operator, Delivery Driver
Chemist - 20 Years of Experience - Near 94602
Tags for this Online Resume: Compliance, Management, Protocol, CMOS, Troubleshooting, Assessments, Evaluate, Manufacturing, OTC, Quality
Not Listed
Tags for this Online Resume: Fabrication, Automotive, Budget Control, Budgeting, CAT, Management, Material Handling, MIG, 5S, Banking Industry
