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Online Resumes with "Analytical Method Transfer"
QC Technical Specialist - 8 years experience - Method transfer, equipment qualification, SOP, Project Management
To contribute to improving business success
Ideal Companies: Pharmaceutical drug product manufacturing/consumer products manufacturing/API
To obtain a challenging scientist position in pharmaceutical/biotech industry allowing me to advance professionally and contribute to company success.
Result oriented professional with many years of experience in pharmaceutical and consumer health care related industry within a cGMP environment. Worked on various solid, semi-solids, liquid, dosage forms. Performed Method development, Method Validation, Method Verification and Method Transfer. Hands on experience on UPLC (Acvity H-Class), HPLC, GC, Auto-Dissolution USP apparatus I,II and IV(Sotax)Flow through Cell, AA,...
Summary * Experienced Quality Assurance scientist in the pharmaceutical and biotechnology industry working for over 17 years in a cGMP and GLP regulated environment. * Lead efforts in the business analysis for the group's business continuity program and the implementation of the Laboratory Information Management Systems (LIMS). * Knowledgeable in Project Management methodologies like 5S, LEAN and Six Sigma. * Skilled in ana...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Microsoft, Microsoft DOS, Microsoft Windows, Applications, Benefits, Business Analysis, Business Analyst, Documentation, Information Technology, pharmaceutical, sap
Summary of Qualifications Highly qualified licensed chemist with experience in Oral Solid Dosage, Parenterals Manufacturing in Quality Control Laboratory, Quality Assurance, Quality System, Quality Operations Technology Transfer and Process Scientist in Technical Services areas. Solid background in analytical methods development and process validation, analytical method transfers and cleaning validation activities. Strong k...
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...
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