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Online Resumes with "endotoxin"



Biologist - 19 Years of Experience - Near 27560

Summary: * 15+years of experience in instrumentation and analytical/microbiological testing. * Conducted routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy * Provided technical support and leadership as pertains to analytical/microbiological testing: verify that results are accurate and complete, recogni...

Tags for this Online Resume: ISO, Management, High Performance Liquid Chromatography (HPLC), Max, Model Driven Architecture, Scheduling, ELISA, Instrumentation, Assessments, Audit

Microbiologist - 9 Years of Experience - Near 28704

To become a member of a quality driven team Over 9 years in Quality Assurance/control, 3+ years in a supervisory position of multi-functional teams with up to 16 direct reports within the microbiology lab. Experienced in team building, protocol design and execution, CAPA investigations, Environmental monitoring, endotoxin screening and bioburden.

Tags for this Online Resume: Manufacturing, Plating, Quality, Quality Assurance, Quality Control, Spectrophotometer, ISO, SAS, Microbiology, Internet, protocol, sas, pharmaceutical, environmental monitoring, supervisor

Biochemist - 4 Years of Experience

Tags for this Online Resume: pharmaceutical, sas, endotoxin, assay, product development, gmp, glp, dhf, sop, Research

Microbiologist

QUALIFICATIONS SUMMARY * LAB: Combined 14 yrs Applied, Clinical/Pharm., Environmental, Industrial exp Quality/R&D Microbiology, Analytical, Process * TECHNIQUES: Aseptic, Pipette, Dilutions, Streaking Isolation, Media Culture Transfer & Maintenance, Genetic & Biochem. Micro ID, Environmental Sampling, Micro & Chem Extraction, Titration * INSTRUMENTATION: Laminar Flow Hoods, BSC Hoods, TOC Shimizu Analyzer (real-time), AAS A...

Tags for this Online Resume: Management, Microbiological Testing, Test, Chemistry, ISO, Microbiology, Complaints, ELISA, Instrumentation, Quality

Production Supervisor - 0 Years of Experience

HIGHLIGHTS OF QUALIFICATIONS 1. Many years of pharmaceutical leadership experience in a Biotech and parenteral drug-manufacturing environment. 2. Diversified experience in sterile manufacturing including bulk manufacturing, aseptic filling, component sterilization, freeze drying, environmental monitoring, inspection and packaging. 3. Knowledge of governmental cGMP, OSHA, DEA regulations and procedures, experience with FDA, ...

Tags for this Online Resume: Packaging, Inventory, Manufacturing, High Performance Liquid Chromatography (HPLC), Leadership, Monitoring, pH Meter, Spectrophotometer, Labor Relations, Occupational Safety and Health Act

Featured Profile

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