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| BACKGROUND SUMMARY |
• Twenty-five years of bioanalytical, pharmacokinetic and drug metabolism
experience in pharmaceutical industry (Pharma, CRO and Consulting).
• Experienced bioanalytical consultant - provided consulting services for 15
Clients and for 125 departmental employees.
• Extensive experience in coordinating multiple simultaneous US and
international bioanalytical projects.
• Proven successful track record of project milestone development and
tracking, managing projects, employees, Clients and technical teams, and in
timely completion of projects.
• Thorough knowledge of the drug development process from lead generation
- lead compound selection – IND – NDA - post marketing support as a member
of multi-functional matrix and project teams.
• Experience in providing support for IND/NDA/BLA submissions and
preparing bioanalytical sections for submission.
• Expertise in bioanalytical chemistry and chromatographic theory, including
methods development, long term storage stability programs and routine
analyses under non-GLP and GLP conditions. Expertise in evaluating and
implementing new technologies and designing innovative solutions to
address bioanalytical issues at ultra-trace detection limits.
• Experience in quantitative separation science, including reversed-phase
normal-phase, chiral, ion interaction, column-switching, solid-phase
extraction, direct injection, indirect photometric, millibore and microbore
HPLC and LC-MS/MS.
experience in pharmaceutical industry (Pharma, CRO and Consulting).
• Experienced bioanalytical consultant - provided consulting services for 15
Clients and for 125 departmental employees.
• Extensive experience in coordinating multiple simultaneous US and
international bioanalytical projects.
• Proven successful track record of project milestone development and
tracking, managing projects, employees, Clients and technical teams, and in
timely completion of projects.
• Thorough knowledge of the drug development process from lead generation
- lead compound selection – IND – NDA - post marketing support as a member
of multi-functional matrix and project teams.
• Experience in providing support for IND/NDA/BLA submissions and
preparing bioanalytical sections for submission.
• Expertise in bioanalytical chemistry and chromatographic theory, including
methods development, long term storage stability programs and routine
analyses under non-GLP and GLP conditions. Expertise in evaluating and
implementing new technologies and designing innovative solutions to
address bioanalytical issues at ultra-trace detection limits.
• Experience in quantitative separation science, including reversed-phase
normal-phase, chiral, ion interaction, column-switching, solid-phase
extraction, direct injection, indirect photometric, millibore and microbore
HPLC and LC-MS/MS.
| Donald L. Reynolds, PhD & Associates, Inc. • 436 NW Highcliffe Dr. • Lee’s Summit, MO 64081 © Copyright 2007 All Rights Reserved Donald L. Reynolds, PhD & Associates, Inc Web Design by www.photographybytuckdesigns.com. |
| DONALD L. REYNOLDS PHD & ASSOCIATES, INC. |
Bioanalytical / Pharmaceutical Consulting Services
PhD & Associates, Inc.
