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Bioanalytical consultant with extensive experience in bioanalytical and pharmaceutical chemistry, quantitative separation science, chromatographic theory and project coordination, in both GLP and non-GLP environments.Specialties: Method development strategies, method troubleshooting, SOP review and development, process optimization, project management, laboratory automation, data and report review, due-diligence laboratory audits
Donald L. Reynolds, Phd & Associates, Inc.
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PresidentDonald L. Reynolds, Phd & Associates, Inc. Apr 2004 - PresentLees Summit, Missouri, United StatesConsultant to pharmaceutical and contract research organizations to support the development of new and generic pharmaceutical products. Provides expertise in the areas of bioanalytical chemistry, drug development, management (scientific, project, Department, business / financial), proposal / milestone costing, development, and tracking, and improvement and systematization of biological analyses.
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Executive Director Project CoordinationQuintiles, Inc. Jun 2001 - Nov 2003Defined the scope of the Project Coordination (PC) function and managed the activities of 5 employees. Responsible for coordinating Departmental Project, Financial and Schedule / Tracking activities. Managed Client contacts, expectations and communications, defined project scope and resource capacity, determined costs for proposed work, reviewed and revised work orders and Client proposals, established and tracked project milestones and prepared Bioanalytical Work Plans and central study files. Represented Client projects and timelines at internal matrix team and scheduling meetings, identifed out of scope or additional work and delivered Bioanalytical product to the Client. Managed Clients, Business Development, Scientific Managers and Bioanalytical Analysts to facilitate timely completion of work, with on-time delivery to the Client.
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Executive Director Bioanalytical Methods DevelopmentQuintiles, Inc. Oct 2000 - Jun 2001Responsible for rapid development and validation of sensitive, selective, high throughput, automated bioanalytical methods to quantitate drugs and metabolites in biological matrices, defining drug / metabolite stability profiles in biological matrices and identifying sample collection, shipment and storage procedures to preserve sample integrity. Ensured that projects were conducted under GLP guidelines and the FDA Guidance and were correctly documented for global submission. Supervised the daily operations of associates in the Bioanalytical Methods Development Department, and was responsible for Departmental budgets, Client proposal pricing, resource allocation and SOPs.
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Associate Director BioanalyticsQuintiles, Inc. Jan 1999 - Oct 2000Coordinated and tracked bioanalytical activities from Discovery - NDA for drug candidates to meet project team and corporate timelines. Developed and validated sensitive and selective bioanalytical methods and performed sample analyses to support non-clinical and clinical studies for selected drug candidates. Responsible for LC-MS/MS and non-LC-MS/MS projects.
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Research Scientist / Scientist BioanalyticsHoechst Marion Roussel Jul 1995 - Dec 1998Provided bioanalytical support for drug discovery and compound selection activities. Developed and validated selective bioanalytical methods at trace levels to quantitate drug molecules and metabolites in biological fluids and performed routine sample analysis activities to support clinical studies for selected drug candidates. -
Scientist Us Clinical Pharmacokinetics / BioanalyticsMarion Laboratories / Marion Merrell Dow May 1989 - Jul 1995Developed and validated selective bioanalytical methods at trace levels to quantitate drug molecules and metabolites in biological fluids and performed routine sample analyses to support clinical studies for selected drug candidates.
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Senior Scientist Pharmacokinetics / Drug MetabolismWarner-Lambert/Parke-Davis Pharmaceutical Research Dec 1982 - May 1989Designed and performed bioanalytical, pharmacokinetic and drug metabolism studies to support non-clinical and clinical development of anti-allergy drug candidates from discovery - NDA. Developed and validated sensitive and selective bioanalytical methods, performed sample analysis, designed and implemented non-clinical pharmacokinetic and drug metabolism studies and designed clinical first-in-man protocol design synopses and for selected drug candidates and relevant metabolites.
Donald Reynolds Skills
Donald Reynolds Education Details
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Pharmaceutical Chemistry -
Pharmaceutical Chemistry -
Pharmacy
Frequently Asked Questions about Donald Reynolds
What company does Donald Reynolds work for?
Donald Reynolds works for Donald L. Reynolds, Phd & Associates, Inc.
What is Donald Reynolds's role at the current company?
Donald Reynolds's current role is Bioanalytical Consultant and President at Donald L. Reynolds, PhD & Associates, Inc..
What is Donald Reynolds's email address?
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What is Donald Reynolds's direct phone number?
Donald Reynolds's direct phone number is +181668*****
What schools did Donald Reynolds attend?
Donald Reynolds attended The University Of Kansas, The University Of Kansas, Ferris State University.
What are some of Donald Reynolds's interests?
Donald Reynolds has interest in Bioanalytical Chemistry, New Technologies, Method Development, Golf, Automation.
What skills is Donald Reynolds known for?
Donald Reynolds has skills like Bioanalytical Chemistry, Methods Development, Method Troubleshooting, Laboratory Automation, Process Optimization, Bioanalysis, Glp, Pharmaceuticals, Drug Development, Pharmaceutics, Clinical Research, Sop.
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