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Online Resumes with "Stability Test"
SUMMARY * 20+ years of analytical chemistry experience in quality control and research and development laboratories. * Knowledgeable of industry regulatory requirements, including FDA, cGMP, GXP, OSHA, ICH and CAPA process & CFR part-111. * Able to design, plan & execute laboratory experiments to evaluate system performance. * Expertise in instrument calibration and preventive maintenance, development and validation of anal...
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
● Utilizes broad technical knowledge and troubleshooting skills to perform testing of a various biological matrices ● Utilizes Labnotes, Watson for transferring the samples and data ● Experiences in current Good Manufacturing Practice (cGMP), current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), requirements and Health Author...
Ideal Companies: Pharmaceutical
Tags for this Online Resume: Manufacturing, High Performance Liquid Chromatography (HPLC), Teamwork, Troubleshooting, Research, Instrumentation, Chemistry, HYGIENE, Millenium (Sw-Fin/Admin), Millennium