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Online Resumes with "method development validation"
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Chemist - 5 Years of Experience - Near 08816
PROFESSIONAL SUMMARY: * More than 3 years analytical chemistry experience in pharmaceutical product companies under cGLP environment. * More than 2 years of hands-on experience in DMPK & bioanalysis using UPLC-MS/MS techniques within the pharmaceutical industry. * Performed chromatographic method development/validation for biological compounds and pharmaceutical drug products. * Demonstrated experience in analytical testing...
Tags for this Online Resume: Data Entry, Analytical Chemistry, Audit, Chemistry, Clinical Research, High Performance Liquid Chromatography (HPLC), Instrumentation, Oracle, UPLC, GLP, Empower, eLIMS
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Scientist - 6 Years of Experience - Near 20705
Self-driven and detail oriented research scientist with over ten years of experience in research and development I have more than 10 years of experience in the following fields * Chromatographic / spectroscopic method development, validation, and analysis (GC - MS, LC - MS, CE, Q-TOF-MS, GC-TOF-MS, MALDI, Electrophoresis, ) * New drug candidate identification from natural sources * Biomarker development * Handling large dat...
Tags for this Online Resume: Cancer, Proteinx, peptide, Mass Spectrophotometer, HPLC, UPLC, MALDI-TOF-MS, Method developmet, GC-MS, MS/MS, Method validation, Chemometric analysis, SIMCA, SPSS, Microsoft
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Chemist - 15 Years of Experience - Near 64468
USA). Performed research with fish hemoglobin (Hb) adducts of PPCPs (namely nitro musk fragrance ingredients) Conducted method development researches for drugs and metabolites, personal care products and nitro aromatics through enzymatic metabolic processes in living organisms. Also monitored occurrence, fate and degradation products of drugs, PPCPs in different water sources and in aquatic organisms such as fish by GC-MS/M...
Tags for this Online Resume: Analytical Chemist,, Research Scientist,, R & D,, Pharmaceutical Company, Agriculture and Environmental, LC-MSMS, GC-MSMS, ICP-OES, Method development and Validation, Instrument trouble shootings, SOPs, GLP, GMP, Analytical Chemistry
Life Scientist - 15 Years of Experience - Near 64137
seeking to contribute 15+ hand-on lab experiences of Biologics products in R & D, Downstream Production and QC, and method development and validation for Pharmaceutical, Clinical Diagnosis, medical devices, and CRO companies.
Tags for this Online Resume: ELISA, Quality, Quality Control, ADA, immunoassay, MDS
Health Technologist - 12 Years of Experience - Near 08536
Key Qualifications * 10+ years experience working in a Clinical Microbiology Laboratory. * Experience in Method Development and Validation. * Sound knowledge of Real-Time PCR, Bio-Plex, Pyro-Sequencing and Gel-Electrophoresis testing. * Attention to detail.
Tags for this Online Resume: Robotics, Sqa (Testing Sw Tool), Microbiology, Assessments, Attention to Detail, Nursing, Patient Care, Test
Biologist
Seeking a position to utilize my knowledge, skills, and abilities in the industry that offers competitive environment, and gain exposure to upcoming technologies while being resourceful, innovative and flexible. Hands-on experience in DNA and Protein isolation, Purification, SDS-PAGE, Cloning, Mammalian Cell Culture, Transfection, HPLC, PCR, RT-PCR, IVD Assay Development, NGS Data Analysis, Western blot, Immunohistochemistr...
Tags for this Online Resume: Documentation, Research, Assessments, CFR Part 11, Chemistry, Distribution, Electrophoresis, ELISA, High Performance Liquid Chromatography (HPLC), Immunization
Chemist - 20 Years of Experience - Near 27514
Seeking a challenging and responsible research and analytical position where my expertise in Quantitative ELISA, DNA extraction, HPLC, AA, water testing and other analytical and bioanalytical techniques will be utilized.
Tags for this Online Resume: Attention to detail, Accurate and Consistent results, Elisa and DNA in Crop Science, LIMS and MS skill, Method Development and Validation, HPLC, AA, TOC, Organized and responsible
Chemist - 20 Years of Experience - Near 02467
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities
Clinical Quality Assurance - 20 Years of Experience - Near 46360
Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...
Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance
