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Online Resumes with "Validation studies"



The Analyst's Analyst

Analyst with good communication and interpersonal skills.

Tags for this Online Resume: Programming, Software Development, Business Analyst, SAS

Patent Attorney

Patent attorney with private practice and in-house experience in preparing and prosecuting patents with an emphasis in various technologies.

Tags for this Online Resume: patent

Featured Profile

PhD Research Scientist With 12+years of Experience in Biomedical Sciences

I am seeking opportunities to contribute as a scientist within preclinical drug development or drug discovery research for the bio-pharmaceutical industry to support the primary or secondary screening and characterization of the molecular mechanism of action of lead drug candidates enabling target validation. I specialize in the development of cell-based assays using genomic, proteomic and biochemical approaches implementin...

Ideal Companies: Biogen Idec, Joule Scientific, Novartis NIBR, Aveo Oncology, Agios, Pfizer, Millipore, Merck, EMD serono, Third rock ventures, Cambridge Scientific, Alkermes, Enlight Biosciences

Tags for this Online Resume: Lentiviral Retroviral shRNA RNA knockdown screens, Flow Cytometry, RTPCR, Immunopreciptations, Reporter assays, Cell based Assays, ELISA, Migration, Stable and Transient Transfections, Genomic and Proteomic Studies, Cloning, Transient siRNA knockdowns, Phenotyping Mammalian cell lines, Gene Overexpression, Subcloning to expression Vectors, Construct Stable Inducible Cell lines, Protein Kinase Assay, Pulse Chase Experiments, Transfection, Transduction, Transformation, Polyoma virus DNA tumor virus replication, Research Scientist, Cell Biology Protein Biochemistry Genetics Molecular Bioliogy Oncology Virology, FACS

Senior staff scientist / Program Manager

Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance

Ideal Companies: medical device companies; adjunct college professor; education manager within a company

Tags for this Online Resume: Product Quality Support, Product stability , medical device software validation, adjunct professor_biology

Featured Profile

Research Scientist

To obtain a position as an engineer or research scientist and be a contributing team member in a challenging and energetic environment.

Tags for this Online Resume: physics, engineering, modeling, simulations, model validation, HPC, programming, data analysis

Clinical Quality Assurance - 20 Years of Experience - Near 94403

QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Ideal Companies: small start-up company

Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)

Medical Scientist - 13 Years of Experience - Near 21136

HIGHLIGHTS OF QUALIFICATIONS: * 2+ years of clinical research monitoring experience and 25+ years pre-clinical experience * Knowledge of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines * Knowledge of FDA regulations * Knowledge of clinical trials for investigative biomedical and pharmaceutical studies. * Good working knowledge of Pharmacology, Epidemiology, Biology, Chemistry, Ph...

Tags for this Online Resume: Cancer, Leadership, Medical, Patient Care, Quality, Quality Assurance, Quality Control, Trauma, Troubleshooting, Phlebotomy

Chemist - 11 Years of Experience - Near 30904

Professional Summary Pharmacist with doctorate degree in analytical chemistry with hands on experience in analytical method development and its validation. Expertise in material chemistry (sol-gel chemistry) and column technology. Have skills and ability to operate wide range of analytical instruments and have basic knowledge of GMP, GLP, 21 CFR Part 210, 211 and validation studies. Currently working in a pharmaceutical ind...

Tags for this Online Resume: Chemistry, Inventory, Pharmaceutical, Regulatory Affairs, Analytical Chemistry, Good Laboratory Practices, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Instrumentation, Its

Lawyer - 20 Years of Experience - Near 30097

Over twenty years' experience in counselling clients in preparing and prosecuting US PCT and foreign patent applications. Proficiencies include mechanical electrical software and business method technologies IP infringement and validity studies licensing supporting IP litigation trademark prosecution and IP portfolio management. US Patent Examiner after law school. Legal experience in boutique IP and large general practice ...

Tags for this Online Resume: Telemetry, Test, Assembly Line, Automotive, Automotive Engineer, Control Systems, Inventory, Inventory Control, Management, Manufacturing, Patent prosecution attorney, Intellectual property attorney

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Clinical Research

PROFESSIONAL SUMMARY: Experienced Clinical Research Professional seeking career advancement with a CRO where I can make a positive contribution by utilizing my clinical research expertise. In-depth knowledge of clinical trial policies and procedures, study protocols, GCP guidelines, ICH guidelines, regulatory clinical trial documentation requirements, IRB documents submittal, sponsor electronic data capture systems for data...

Tags for this Online Resume: Chemotherapy, Clinical Research, Collection, Gastrointestinal, Oncology, PEDIATRIC, Protocol, Support

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