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Online Resumes with "method development validation"
Analytical chemist - 15+ years eperience HPLC, LCMS; pharma-biotech
HPLC and LCMS method development and validation in support of small molecule drug discovery programs, reglatory submissions, or related area
Tags for this Online Resume: HPLC and UHPLC, LCMS and LCMS/MS, analytical chemistry, method development and validation, cGMP and GLP, regulatory submissions
Environmental Scientist
HIGHLIGHTS OF QUALIFICATIONS * 7 years combined background and experience in water and wastewater treatment research * Experience in implementation and certification ISO 14001 * Design, implementation and start-up of lab and pilot systems * Experience with filtration systems such as reverse osmosis membranes * Experience in advanced analytical techniques, including HPLC - MS, HPLC-orbitrap, UV/VIS, TOC, ion chromatograph, F...
Tags for this Online Resume: Research, Audit, High Performance Liquid Chromatography (HPLC), Integrate, Internal audit, ISO, Management, Travel, Water Treatment
Pharmaceutical Scientist
ver fifteen years of solid experience in pharmaceutical Quality Assurance, Quality Control, Stability, Analytical methods development, Validation, Instrumentation, Lab supervisor and Academic. Accomplished, results-oriented individual with expertise in pharmaceutical area. Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR, AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of cGM...
Ideal Companies: J&J, Celgene, Merck
Tags for this Online Resume: Scientist
Chemist - 20 Years of Experience - Near 01876
SUMMARY: * 30 years in the Pharmaceutical Industry including Quality Control, development, tech transfer, validation and project management * Pre-clinical and Phase I to Phase III Analytical Method Development, Qualification/ Validation * Excellent writing and communication skills (wrote SOP's, protocols and reports for method development, tech transfer as well validation programs). * Method development for proteins and sma...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Management, Project Coordinator, Project Management, SEC, Securities and Exchange Commission (SEC), Xray, Quality, Quality Assurance, Quality Control
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
System Administrator - 0 Years of Experience
Life cycle Management and documentation of specification in Laboratory Information Management Systems (LabWare LIMS) in cGMP environment. * Create and Manage Drug substance, Drug product, and Raw materials specifications in LIMS against the master specification copy available in the Document management system. * Accurately configure Analysis's including Strength, Impurities content, Water content, Content uniformity, Resid...
Tags for this Online Resume: Acceptance Testing, Audit, Configure, Document Management, Documentation, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Management, Manufacturing, Pharmaceutical Industry
